Paediatric Hepatic International Tumour Trial

2024-516110-38-00 Protocol RG_15-114 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 6 Mar 2018 · Status Ongoing, recruiting · 10 EU/EEA countries · 90 sites · Protocol RG_15-114

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 449
Countries 10
Sites 90

Hepatoblastoma and Hepatocellular Carcinoma

Group A - Very Low-Risk HB Patients, depending on their tumour histology, will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies. Group B - Low-Risk HB In patients who are resected after 2 courses (Group B1), the aim …

Key facts

Sponsor
The University Of Birmingham
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
6 Mar 2018 → ongoing
Decision date (initial)
2025-01-27
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Deutsche Kinderkrebsstiftung (DKKS) · European Union Horizon 2020 research andinnovation programme: Grant No. 668596 · St.Anna Children`s Cancer research Institute · Little Princess Trust

External identifiers

EU CT number
2024-516110-38-00
EudraCT number
2016-002828-85
ClinicalTrials.gov
NCT03017326
ISRCTN
ISRCTN17869351

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Group A - Very Low-Risk HB
Patients, depending on their tumour histology, will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies.

Group B - Low-Risk HB
In patients who are resected after 2 courses (Group B1), the aim is to evaluate whether the outcome with a total of 4 cycles of treatment is not inferior to those receiving a total of 6 cycles of treatment.
Patients who are not resected after 2 courses (Group B2) will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies.

Group C - Intermediate Risk HB
To compare outcome and toxicity in patients treated with:
(i) cisplatin/5-fluorouracil/vincristine/doxorubicin (C5VD);
(ii) SIOPEL-3 high-risk chemotherapy with cisplatin, carboplatin and doxorubicin (SIOPEL-3HR);
(iii) dose compressed cisplatin monotherapy (CDDP-M).

Group D - High-Risk HB
In patients who have cleared metastatic disease with induction chemotherapy, treatment is standard as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies.
In patients who have not cleared metastatic disease with induction chemotherapy +/- surgery, the aim is to compare the outcomes of the following post-induction treatments:
(i) carboplatin and doxorubicin (CD) alternating with carboplatin and etoposide (CE);
(ii) carboplatin and doxorubicin (CD) alternating with vincristine and irinotecan (VI).

Group E - Resected HCC
Patients will be treated with standard treatment as defined by the protocol. The primary aim for this group is to collect samples for biological and toxicity studies.

Group F - Unresected HCC: Patients with microscopic residual disease after resection will be included in this group.
The aim is to determine whether the addition of gemcitabine, oxaliplatin and sorafenib (GEMOX + sorafenib) to cisplatin, doxorubicin and sorafenib (PLADO+Sorafenib), in a dose compressed fashion improves outcome.

Secondary objectives 4

  1. - To report outcome (including EFS, OS, toxicity following treatment and surgical outcome) in all patient groups.
  2. To validate a new global risk stratification, defined by Children’s Hepatic Tumours International Collaboration (CHIC).
  3. To evaluate clinically relevant factors, including the following: o To provide a comprehensive and highly-validated panel of diagnostic and prognostic biomarkers; o To determine if paediatric HCC is a biologically different entity to adult HCC; o To develop genomic and/or biomarker analysis to predict children who may have an increased risk of developing toxicity with chemotherapy.
  4. To establish a collection of clinically and pathologically-annotated biological samples.

Conditions and MedDRA coding

Hepatoblastoma and Hepatocellular Carcinoma

VersionLevelCodeTermSystem organ class
21.0 LLT 10019828 Hepatocellular carcinoma non-resectable 10029104
20.0 PT 10062001 Hepatoblastoma 100000004864
20.0 LLT 10019824 Hepatoblastoma resectable 10029104
20.0 LLT 10019821 Hepatoblastoma non-resectable 10029104
21.0 LLT 10019830 Hepatocellular carcinoma resectable 10029104
20.0 PT 10073071 Hepatocellular carcinoma 100000004864
20.0 LLT 10019822 Hepatoblastoma NOS 10029104
27.0 LLT 10077738 Hepatocellular carcinoma metastatic 10029104

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 PHITT
The following drugs are regarded as Investigational Medicinal Products (IMPs) for the purposes of this trial: • Cisplatin • Carboplatin • Doxorubicin • Fluorouracil (5-FU) • Vincristine • Irinotecan • Etoposide • Sorafenib • Gemcitabine • Oxaliplatin All IMPs are expected to be held as routine hospital stock and should therefore be stored and handled according to local institutional policy. Labels will be produced by each NCC in accordance with Annex 13 guidelines and national legislation. Treatment should be prepared and administered according to the relevant Summary of Product Characteristics (SmPC) and local practice unless the trial protocol requires otherwise. In the event of scheduling conflicts due to administrative reasons, dosing and study evaluations may take place on the designated day +/- 3 days. Current guidelines for the surgical management of liver tumours should be referred to.
 Randomised Controlled None Group A: Resected - Very Low-Risk Hepatoblastoma - These patients will have a primary resection of their tumour. Selection of the appropriate patients for consideration for up-front surgery requires good quality imaging at diagnosis and careful radiological review anticipating clear resection margins, especially adjacent to vascular structures. In borderline cases we would recommend patients enter Arm B of the protocol and receive preoperative chemotherapy.

Following surgical resection, all patients MUST have rapid central review of their pathology with an expected central review response within 14 days to confirm eligibility for this treatment group. Centrally confirmed WDF patients will receive no adjuvant chemotherapy. All non-WDF patients will receive 2 cycles of cisplatin chemotherapy.

Patients in this group will be divided into two cohorts depending on the result of the histology subtype:
• Group A1: Patients with WDF histology will receive no further adjuvant chemotherapy (follow up for disease progression and death only)
• Group A2: Patients with Non-WDF histology will receive 2 cycles of standard dose cisplatin
Group B: Unresected - Low-Risk Hepatoblastoma - These patients will have a tumours deemed unresectable at diagnosis but no other adverse features. The main aim of this group is to compare treatment with 2 or 4 cycles of post-operative chemotherapy. Selection of patients for consideration for early resection requires good quality imaging at diagnosis and careful radiological review anticipating clear resection margins especially adjacent to vascular structures.
PLEASE NOTE THAT RESECTION OF THE PRIMARY TUMOUR MAY OCCUR EARLY (WITHIN 2 CYCLES / 4 WEEKS FROM START OF CHEMOTHERAPY) IN THE PATIENT PATHWAY. SURGICAL PLANNING FOR A POTENTIAL RESECTION SHOULD THEREFORE COMMENCE AT THE TIME OF INITIAL DIAGNOSIS
Patients resected after 2 cycles of chemotherapy will be eligible for a randomisation comparing 2 vs. 4 cycles of post-operative chemotherapy. Patients should normally be randomised within 14 days of surgery.
Eligibility Criteria for Group B1 randomisation:
• Completed two cycles of cisplatin
• Primary tumour resected following 2 cycles of cisplatin
Patients not resected after 2 cycles of chemotherapy should continue to receive cisplatin in the absence of disease progression and follow the standard approach of resection after 4 cycles of chemotherapy followed by 2 post-operative cycles.
Patients who are not resected after receiving 4 cycles of cisplatin treatment should continue to cycles 5&6 of cisplatin and should be considered for transplantation and, if not already considered, referred to a transplant centre. Patients deemed unresectable after 6 cycles of cisplatin should be considered for further salvage strategies at the discretion of the treating centre and should be referred for consideration of transplantation. If in doubt please contact one of the chemotherapy subcommittee members.
Group C: Unresected - Intermediate Risk Hepatoblastoma - Patients in Group C will have locally advanced tumours, including PRETEXT I-III tumours with a positive annotation factor and all PRETEXT IV tumours. Early referral (at the time of diagnosis) to a transplant centre is encouraged so that sufficient time can be allowed for the surgical planning and/or transplant workup to take place. For the purposes of this study, consultation will be defined and may be accomplished in one of two ways:
1) The FIRST TIME the patient is seen face to face by the transplant physician/team in the same institution or another institution.
2) The FIRST TIME radiographic films and referral material are sent to the transplant physician/team at the same or another institution and are formally reviewed by the transplant physician/team. The transplant physician/team will communicate the result of this consultation back to the referring physician.
Patients will be randomised to one of 3 chemotherapy arms SIOPEL-3HR, C5VD or higher dose CDDP-M. The resection of the primary tumour can be considered at ANY point during therapy. The protocol gives an outline of the timing of response evaluations and possible surgical intervention, but this is not mandated. However, irrespective of the timing of surgery, patients should complete all planned protocol cycles of chemotherapy (including post-transplantation), and definitive surgery should occur at least prior to the last 2 cycles of chemotherapy whenever possible.
Group D: High-Risk Hepatoblastoma - These patients may have pulmonary metastatic disease. Often, patients will also have challenging primary tumours, and a significant number may be considered suitable for transplantation (assuming a lung CR can be achieved). We would encourage early referral (at the time of diagnosis) to a transplant centre so that sufficient time can be allowed for the surgical planning and/or transplant workup to take place as well as to avoid extra cycles of chemotherapy that may accompany delayed transplant consultation.

Patients will receive initial chemotherapy according to the cisplatin-intensive SIOPEL-4 regimen. Following 3 blocks of chemotherapy, patients will be stratified into 2 risk groups. In Group D1, patients will either have had a chemotherapy-induced lung CR, or will be rendered a lung CR by surgical metastectomy (recommended before resection of the primary tumour). These patients will have chemotherapy consolidation with carboplatin/doxorubicin. The timing of the resection of the primary tumour (including transplant) can be planned at any time after completion of the A blocks of induction therapy. Patients should receive all planned protocol doses of therapy. If surgical resection of the primary tumour is delayed until the end of therapy, no further post-operative chemotherapy should be given.
Patients who have not achieved a lung CR (either with chemotherapy and/or surgery) at the end of block A3 will be randomised (Group D2) to intensified consolidation therapy of carboplatin/doxorubicin with either carboplatin/etoposide or vincristine/irinotecan.
Eligibility Criteria for Group D2 randomisation:
• Completed three blocks of induction treatment;
• Metastases not cleared at the end of induction.

Surgical resection of the primary tumour can be considered at any time after the initial A blocks of induction therapy. Lung metastectomy should be considered in all patients if continuing to respond to consolidation therapy. Patients with delayed lung CR should still be considered for transplant, if applicable. Patients with residual disease (primary and/or metastatic) at the end of planned therapy should be discussed with one of the study coordinators.
Group E: Resected Hepatocellular Carcinoma - These patients have primary completely resected HCC with microscopically uninvolved surgical margins. Patients fall into two groups:
• Group E1: Patients who have an underlying predisposition to HCC through genetic, viral or metabolic conditions, which often result in underlying cirrhosis. Tumours may be picked up on routine screening or as a coincidental finding in the explanted liver following transplantation. Tumours are often small and localized. Given the poor tolerability of chemotherapy, either due to underlying liver disease or transplantation, the recommendation is for these patients to receive no adjuvant chemotherapy.
• Group E2: Patients with de novo HCC, which includes fibrolamellar. Patients will receive 4 cycles of PLADO chemotherapy.
Group F: Unresected/Metastatic Hepatocellular Carcinoma - These patients have unresected and/or metastatic HCC. Patients with microscopic/residual disease after resection will be included in this group. Tumours in this population of patients are often large and remain a surgical challenge even following a response to chemotherapy. Since complete surgical resection is a prerequisite for cure, the outlook for these patients has historically been poor. The strategy in this arm of the study is to evaluate chemotherapy response in order to drive more tumours into being resected either through partial hepatectomy or transplantation. Patients will be randomised to preoperative chemotherapy consisting of either PLADO+sorafenib or PLADO/GEMOX+sorafenib.
Given the surgical challenges posed by these tumours and the need to consider transplantation as an option, early referral (at the time of diagnosis) to a transplant centre is encouraged so that sufficient time can be allowed for the surgical planning and/or transplant workup to take place.

Patients in this group will be randomised to receive one of the following regimens:
• PLADO + Sorafenib
• PLADO + Sorafenib / GEMOX + Sorafenib

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 36

  1. General criteria • Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: a) The patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy. b) There is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.). c) Uncorrectable coagulopathy.
  2. Group A2 - Treatment arm • Central pathology review confirming non-WDF histology.
  3. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  4. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
  5. Group B • Patient meets Low Risk definition according to CHIC Guidelines
  6. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  7. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
  8. Group C • Patient meets Intermediate Risk definition according to CHIC Guidelines
  9. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  10. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
  11. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
  12. General criteria • Age ≤30 years
  13. Group D • Patient meets High Risk definition according to CHIC Guidelines
  14. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  15. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
  16. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
  17. Group E - At diagnosis: • Patient has been diagnosed with HCC
  18. • Tumour has been resected with negative margins Group E1
  19. • HCC secondary to underlying liver disease
  20. Group E2 • HCC de novo, including fibrolamellar
  21. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  22. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
  23. General criteria • Written informed consent for trial entry
  24. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age
  25. Group F • Patient diagnosed with HCC
  26. • Tumour locally assessed as un-resectable, or metastatic HCC disease
  27. • Adequate renal function determined by: o Serum creatinine in the normal range based on age appropriate local reference values or glomerular filtration rate (GFR) ≥60mL/min/1.73m2
  28. • Adequate cardiac function determined by: o Shortening fraction ≥28% by local assessment method o OR Ejection fraction ≥47% by local assessment method
  29. • Adequate haematology/biochemistry: o Absolute neutrophil count (ANC) >0.75 x 109/L o Platelet count >75 x 109/L o International normalised ratio(INR)/Prothrombin time (PT) <1.2x ULN for age-based local reference values o K, Mg, Ca within normal range for age o Qt/QTc interval =/<450msec for males, =/<470msec for females
  30. For Allocation/Randomisation to Treatment Group: All Groups • Written Informed Consent for trial treatment participation
  31. For Allocation/Randomisation to Treatment Group: All Groups • Patient assessed as fit to receive group specific treatment
  32. For Allocation/Randomisation to Treatment Group: All Groups • For females of child-bearing potential, a negative pregnancy test prior to trial entry is required. Any patient who is of reproductive age must agree to use adequate contraception for the duration of the trial.
  33. Group A (no treatment arm) - At diagnosis: • Resected Tumour.
  34. Group A1 – No treatment arm • Patient meets Very Low Risk definition according to CHIC guidelines.
  35. Group A1 – No treatment arm • Central pathology review confirming WDF histology.
  36. Groups B, C & D - Real time review required if age>8 and/or AFP<100 – confirm HB diagnosis

Exclusion criteria 14

  1. • Any previous chemotherapy or currently receiving anti-cancer agents
  2. • Recurrent disease
  3. • Previously received a solid organ transplant
  4. • Uncontrolled infection
  5. • Unable to follow the protocol for any reason
  6. • Second malignancy
  7. • Pregnant or breastfeeding women
  8. Treatment Group Specific Exclusion Criteria Group C: • Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
  9. Group D: • Chronic inflammatory bowel disease and/or bowel obstruction
  10. • Concomitant use with St John’s Wort which cannot be stopped prior to start of trial treatment
  11. Group F: • Peripheral Sensitive Neuropathy with functional impairment
  12. • Personal or family history of congenital long QT syndrome
  13. • QT/QTc interval >450msec for men and >470msec for women (corrected measurement of QT according to BAZETT formula)
  14. • Patients who are unable to swallow tablets , where an oral solution is not available or approved

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

  1. Event Free Survival (EFS) as defined as the time from randomisation (or registration into the trial for non-randomised patients) to the first failure event. Patients who have not had an event will be censored at their last follow-up date.
  2. Progression of existing disease or occurrence of disease at new sites
  3. Death from any cause prior to disease progression
  4. Diagnosis of a second malignant neoplasm.
  5. Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria. The assessment will be performed after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOx+S in Group F patients. Patients who are not assessable for response, e.g. because of early stopping of treatment or death, will be assumed to be non-responders.

Secondary endpoints 7

  1. Failure-free survival (FFS): defined as per EFS (above) with the addition of failure to go to resection.
  2. Overall survival (OS): defined as the time from randomisation (or enrolment for non-randomised patients) to death from any cause. Patients who have not died will be censored at their last follow-up date.
  3. Toxicity will be recorded in relation to each cycle of randomised treatment and will be categorised and graded using Common Terminology Criteria for Adverse Events (CTCAE)
  4. Chemotherapy-related cardiac, nephro- and oto- toxicity will be recorded in relation to each cycle of non-randomised treatment and will be categorised and graded using common terminology criteria for adverse events (CTCAE)
  5. Hearing loss will be measured according to the SIOP Boston Scale for oto-toxicity. The assessment will be performed at end of treatment and follow up.
  6. Best Response as defined as Complete Response (CR) and Progressive Response (PR) and is defined in the protocol (Appendix 8) based on radiological response and AFP decline. Best response will be measured throughout treatment period and follow up. Patients who are not assessable for response , e.g. because of early stopping of treatment or death - will be assumed non-responders
  7. Surgical resectability as defined as complete resection, partial resection or transplant following randomisation (or enrolment for non-randomised patients).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 38

Irinotecan

SUB08295MIG · Substance

Active substance
Irinotecan
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
50 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION OR ORAL SOLUTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION OR ORAL SOLUTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION OR ORAL SOLUTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION OR ORAL SOLUTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
600 mg/m2 milligram(s)/sq. meter
Max total dose
3600 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance
Vincristine Sulfate
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
12 mg milligram(s)
Max treatment duration
15 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance
Vincristine Sulfate
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
12 mg milligram(s)
Max treatment duration
15 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine Hydrochloride

SUB02324MIG · Substance

Active substance
Gemcitabine Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
4000 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/square meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
3900 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
3900 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
3900 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
3900 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
3900 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
30 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
23 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sorafenib

SUB23139 · Substance

Active substance
Sorafenib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
300 mg/m2 milligram(s)/sq. meter
Max total dose
32400 mg/m2 milligram(s)/sq. meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
15 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
15 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/sq. meter
Max total dose
1200 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

The University Of Birmingham

14 Total trials 8 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
The University Of Birmingham
Address
Vincent Drive
City
Birmingham
Postcode
B15 2TT
Country
United Kingdom

Scientific contact point

Organisation
The University Of Birmingham
Contact name
Clinical Trial Coordinator

Public contact point

Organisation
The University Of Birmingham
Contact name
Clinical Trial Coordinator

Locations

10 EU/EEA countries · 90 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 11 5
Belgium Ongoing, recruiting 16 6
Czechia Ongoing, recruiting 12 2
France Ongoing, recruiting 82 29
Germany Ongoing, recruiting 42 17
Ireland Ongoing, recruiting 7 1
Netherlands Ongoing, recruiting 21 1
Norway Ongoing, recruiting 10 4
Poland Ongoing, recruiting 34 10
Spain Ongoing, recruiting 57 15
Rest of world
United Kingdom, Israel, Switzerland
 — 157 —

Investigational sites

Austria

5 sites · Ongoing, recruiting
Johannes Kepler University Linz
Med Campus IV, Krankenhausstrasse 26-30, 4020, Linz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Kinderspital / Abteilung für Kinder- und Jugendheilkunde, Strasse Veiter Strasse 46, 5621, Sankt Veit Im Pongau
Medizinische Universitaet Innsbruck
Pädiatrie I Department für Kinder- und Jugendheilkunde, Anichstrasse 35, 6020, Innsbruck
St. Anna Kinderspital GmbH
2b, Kinderspitalgasse 6, Alsergrund, Vienna
Medical University Of Graz
Klinische Abteilung für Pädiatrische Hämatologie/Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz

Belgium

6 sites · Ongoing, recruiting
Cliniques Universitaires Saint-Luc
Hémotologie et oncologie pédiatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Regional De La Citadelle
Hémotologie et oncologie pédiatrique, Boulevard Du Douzieme De Ligne 1, 4000, Liege
UZ Leuven
Hémotologie et oncologie pédiatrique, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Hémotologie et oncologie pédiatrique, Corneel Heymanslaan 10, 9000, Gent
Antwerp University Hospital
Hémotologie et oncologie pédiatrique, Drie Eikenstraat 655, 2650, Edegem
UZ Brussel
Hémotologie et oncologie pédiatrique, Laarbeeklaan 101, 1090, Jette

Czechia

2 sites · Ongoing, recruiting
Fakultni Nemocnice Brno
Department of Pediatric Oncology, Jihlavska 340/20, Bohunice, Brno
Charles University Hospital
Department of Pediatric Hematology and Oncology, V Uvalu 84/1 Motol, 150 00, Prague

France

29 sites · Ongoing, recruiting
Centre Hospitalier Universitaire De Rennes
Hématologie-oncologie Pédiatrique, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Leon Berard
Oncologie Pédiatrique, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Regional Universitaire De Tours
Oncologie - Hématologie Pédiatrique, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
University Hospital Of Clermont-Ferrand
Hématologie Oncologie Pédiadrique - SHOP, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire Reims
Hématologie-oncologie Pédiatrique, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Universitaire De Bordeaux
Onco-Hématologie Pédiatrique, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Saint Etienne
Hémotologie et oncologie pédiatrique, 25 Boulevard Pasteur, 42100, Saint-Etienne
Centre Oscar Lambret
Unité d'Oncologie Pédiatrique, 3 Rue Frederic Combemale, 59000, Lille
Assistance Publique Hopitaux De Paris
Hématologie et oncologie Pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Immuno-Hémato-Oncologie Pédiatrique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Les Hopitaux Universitaires De Strasbourg
Onco-Hématologie Pédiatrique, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Caen Normandie
Onco-Hématologie Pédiatrique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Hématologie-oncologie Pédiatrique, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Nantes
Hémotologie et oncologie pédiatrique, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Centre Hospitalier Regional Et Universitaire De Brest
Pédiatrie Spécialisée, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
Institut Gustave Roussy
Cancérologie de l’Enfant et de l’Adolescent, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Poitiers
Onco-hématologie pédiatrique, 2 Rue De La Miletrie, 86000, Poitiers
Institut Curie
Pédiatrique, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire D'Angers
Unité Hémato-Immuno-Oncologie Pédiatrique, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De La Reunion
Oncologie et Hématologie Pédiatrique, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Universitaire De Nice
Onco-Hématologie Pédiatrique, 4 Avenue Reine Victoria, 06000, Nice
Centre Hospitalier Regional De Marseille
Hématologie-oncologie Pédiatrique, 80 Rue Brochier, 13005, Marseille
Centre Hospitalier Universitaire Rouen
Immuno Hémato Onco Pédiatrie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Dijon
Onco-Hémato-Pédiatrie, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Centre Hospitalier Universitaire De Toulouse
Oncologie - Hématologie Pédiatrique, 2 Rue Viguerie, Tsa 80035, Toulouse
CHRU De Nancy
Onco-Hématologie Pédiatrique, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier Universitaire De Montpellier
Hémotologie et oncologie pédiatrique, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire Amiens Picardie
Onco-Hématologie Pédiatrique, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHU Besancon
Hématologie Oncologie Pédiatrique, 2 Place Saint Jacques, Cs 51804, Besancon Cedex

Germany

17 sites · Ongoing, recruiting
Goethe University Frankfurt
Zentrum für Kinder- und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Ludwig-Maximilians-Universitaet Muenchen
Department of Paediatric Hematology and Oncology, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Essen AöR
Klinik für Kinderheilkunde III, Hufelandstrasse 55, Holsterhausen, Essen
Medizinische Hochschule Hannover
Päd. Onkologie und Hämatologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Tuebingen AöR
Abt. Kinderheilkunde I, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaetsklinikum Augsburg
Kinderklinik, Stenglinstrasse 2, Kriegshaber, Augsburg
University Hospital Cologne AöR
Zentrum für Kinderonkologie und – hämatologie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum des Saarlandes AöR
Klinik für Pädiatrische Hämatologie / Onkologie, Kirrberger Strasse 100, 66421, Homburg
Medical Center - University Of Freiburg
Zentrum für Kinderheilkunde und Jugendmedizin, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Zentrum für Kinder- und Jugendmedizin, Kriegsbergstrasse 62, Mitte, Stuttgart
Universitaetsklinikum Wuerzburg AöR
Zentrum für Kinder, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinder- und Jugendmedizin 1, Sektion für Kinderonkologie und -hämatologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Leipzig AöR
Kinder- und Jugendmedizin Kinder-Hämatologie und -Onkologie, Haus C, Liebigstrasse 21, Leipzig
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Klinik und Poliklinik für Kinder- und Jugendmedizin Pädiatrische Hämatologie/Onkologie/Hämostaseolog, Langenbeckstrasse 1, Oberstadt, Mainz
Charite Universitaetsmedizin Berlin KöR
Otto-Heubner-Centrum für Kinder- und Jugendmedizin Klinik für Pädiatrie m.S. Onkologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Bonn AöR
Zentrum für Kinderheilkunde Abt. Päd. Hämatologie/Onkologie, Nussallee 10, Poppelsdorf, Bonn
Klinikum Dortmund gGmbH
Klinik für Kinder- und Jugendmedizin Kinderhämatologie und -onkologie, Beurhausstrasse 40, Mitte, Dortmund

Ireland

1 site · Ongoing, recruiting
Children's Health Ireland
Oncolgy, Cooley Road, Crumlin, Dublin 12

Netherlands

1 site · Ongoing, recruiting
Prinses Maxima Centrum voor Kinderoncologie B.V.
Solid Tumours, Heidelberglaan 25, 3584 CS, Utrecht

Norway

4 sites · Ongoing, recruiting
St. Olavs Hospital HF
Dep.of pediatric hematology and oncology, Ragnhilds Gate 15, 7030, Trondheim
Helse Bergen HF
Dep.of pediatric hematology and oncology, P. O. Box 1400, 5021, Bergen
Oslo University Hospital HF
Dep.of pediatric hematology and oncology, Taarnbygget, Kirkeveien 166, Oslo
Universitetssykehuset Nord-Norge HF
Dep.of pediatric hematology and oncology, Sykehusvegen 38, 9019, Tromsoe

Poland

10 sites · Ongoing, recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Instytut Pomnik Centrum Zdrowia Dziecka, Klinika Onkologii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Katedra i Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej, Ul. Borowska 213, 50-556, Wroclaw
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhifa, Klinika Pediatri, Onkologii i Hematologi, Ul. Jerzego Waszyngtona 17, 15-274, Bialystok
Uniwersyteckie Centrum Kliniczne
Klinika Pediatrii Hematologii Onkologii, Gdanski Uniwersytet Medyczny, Ul. Debinki 7, 80-952, Gdansk
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Klinika Pediatrii, Onkologii i Immunologii Dzieciecej, Pomorski Uniwersytet Medyczny w Szczecinie, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Dzieciecy W Krakowie
Klinka Onkologii i Hematologii Dziecięcej, Instytut Pediatrii Wydział Lekarski Uniwersytetu Jagiello, Ul. Wielicka 265, 30-663, Cracow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Hematologii i Onkologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Górnośląskie Centrum Zdrowia Dziecka im. Św. Jana Pawła II Samodzielny Publiczny Szpital Kliniczny, Ul. Medykow 16, 40-752, Katowice
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Klinika Onkologii, Hematologii i Transplantologii Pediatrycznej Szpital Kliniczny im. Karola Jonsche, Ul. Szpitalna 27/33, 60-572, Poznan
Medical University Of Gdansk
Oncology, Ul. Marii Sklodowskiej-Curie 3a, 80-210, Gdansk

Spain

15 sites · Ongoing, recruiting
Hospital Universitario Hm Monteprincipe
Pediatric Oncology and Hematology, Avenida De Monteprincipe 25, 28660, Boadilla Del Monte
Hospital Universitario 12 De Octubre
Pediatry, Avenida De Cordoba Sn, 28041, Madrid
Hospital General Universitario Gregorio Maranon
Pediatry, Calle Del Doctor Esquerdo 46, 28007, Madrid
University Hospital Virgen Del Rocio S.L.
Pediatric Oncology Unit, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Reina Sofia
Pediatry, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Regional De Malaga
Pediatric Oncology Unit, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario De Canarias
Pediatric Oncology and Haematology Unit, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital Universitario La Paz
Pediatric Haemato-Oncology, Paseo De La Castellana 261, 28046, Madrid
University Hospital Son Espases
Pediatry, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario De Cruces
Pediatric Oncology and Haematology, Cruces Plaza S/n, 48903, Barakaldo
University Clinical Hospital Virgen De La Arrixaca
Pediatry, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitari Vall D Hebron
Pediatric Oncology, Haematology and bone Marrow Transplantation, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Pediatric Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Miguel Servet
Pediatry, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Sant Joan De Deu Barcelona
Pediatric Oncology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2020-01-31 2020-01-31
Belgium 2019-02-27 2019-02-27
Czechia 2019-11-26 2019-11-26
France 2019-01-10 2019-01-15
Germany 2019-12-09 2019-12-09
Ireland 2019-07-03 2019-07-05
Netherlands 2019-07-29 2019-07-30
Norway 2018-03-06 2019-02-25
Poland 2020-04-28 2020-04-28
Spain 2018-05-03 2018-05-03

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 306 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1 ProtocolConsolidatedEN EN3Redacted 3
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Recruitment arrangements (for publication) L1 BlankPlaceholderENEN 1
Subject information and informed consent form (for publication) GOT_Information Sheet for 16plus_GroupA2_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for 16plus_GroupB_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for ParentGuardian_GroupA2_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for ParentGuardian_GroupF_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for ParentGuardian_Trial Entry_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for Patient 16plus_GroupC_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for Patient 16plus_GroupD_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for Patients 16plus_GroupE2_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for Patients 16plus_GroupF_1PL PL 1
Subject information and informed consent form (for publication) GOT_Information Sheet for Patients 16yrplus_Trial Entry_1PL PL 1
Subject information and informed consent form (for publication) Informatie zwangere studiepatient_v1_2 27Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) L1 ICF age 16_Treat_1 GRP FIE ENRedacted 1
Subject information and informed consent form (for publication) L1 ICF ICF_ParentGuardian_Treatment_1PL PL 1
Subject information and informed consent form (for publication) L1 ICF ICF_ParentGuardian_Trial Entry_1PL PL 1
Subject information and informed consent form (for publication) L1 ICF ICF_Patients 16plus_Treatment_1PL PL 1
Subject information and informed consent form (for publication) L1 ICF ICF_Patients 16plus_Trial Entry_1PL PL 1
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Enregistrement_V5_1_200722FR FR 5.1
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe A2_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe B_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe C_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe D_V5_1_200722FR FR 5.1
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe E2_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Mineurs 15to18_Groupe F_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Parents_Enregistrement_V5_1_200722FR FR 5.1
Subject information and informed consent form (for publication) L1 ICF InfoCons_Parents_Groupe A2_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Parents_Groupe B_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Patients 18plus_Groupe F_V5_0_200107FR FR 5
Subject information and informed consent form (for publication) L1 ICF InfoCons_Patients_Groupe D_V5_1_200722FR FR 5.1
Subject information and informed consent form (for publication) L1 ICF Parent_Treat_1 GRP FIE ENRedacted 1
Subject information and informed consent form (for publication) L1 ICF ParentGuardian_Treatment_1IE ENRedacted 1
Subject information and informed consent form (for publication) L1 ICF ParentGuardian_Trial Entry_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 ICF Patients 16plus_Treatment_1 IE ENRedacted 1
Subject information and informed consent form (for publication) L1 ICF Patients 16plus_Trial Entry_2 IE ENRedacted 2
Subject information and informed consent form (for publication) L1 ICFPIS IS_A2_15_17let_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_A2_18plus_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_A2_rodie_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_B_12_14let_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_B_15_17let_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_B_18plus_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_B_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_C_12_14let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_C_15_17let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_C_18plus_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_C_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_D_12_14let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_D_15_17let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_D_18plus_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_D_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_E2_12_14let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_E2_15_17let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_E2_18plus_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_E2_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_F_12_14let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_F_15_17let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_F_18plus_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_F_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_vstup_do_studie_12_14let_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_vstup_do_studie_18plus_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS IS_vstup_do_studie_rodie_v3_17Oct2018CZ CZ 3
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardian_GroupA2_V1_2_15Nov2018 BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardian_GroupB_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardian_GroupC_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardian_GroupD_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardian_GroupE2_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsGuardianGroupFV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_Groupe D_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_Groupe E2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_Groupe F_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_GroupeA2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_GroupeB_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS ParentsTuteurs_Inclusion Etude_V3 20Mai2020 BE FR 3
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17 ans_Inclusion Etude_V3 20Mai 2020 BE FR 3
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17ans_Groupe C_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17ans_Groupe D_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17ans_Groupe E2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17ans_GroupeA2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12_17ans_GroupeB_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17GroupDV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17GroupE2V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17yrGroupA2V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17yrs_GroupCV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17yrsGroupBV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 12to17yrStudy EntryV3_20May2020BE EN 3
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18ansplus_Inclusion Etude_V3 20Mai20120 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_GroupA2_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_GroupBV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_GroupCV1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_GroupD_V1_2 15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_GroupE2 _V1_2 _15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plus_Study EntryV3_20May2020BE EN 3
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plusans_Groupe C_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plusans_Groupe D_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plusans_Groupe E2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plusans_GroupeA2_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 18plusans_GroupeB_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patient 8_11 ans_Inclusion Etude_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patiente Enceinte_v1_2 27Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patients 12_17ans_Groupe F_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patients 12to17_GroupF_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patients 18plus_GroupF_V1_2_15Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Patients 18plusans_Groupe F_V1_2 15Nov2018 BE FR 1.2
Subject information and informed consent form (for publication) L1 ICFPIS Pregnant Patient_v1_2_27Nov2018BE EN 1.2
Subject information and informed consent form (for publication) L1 PIS Addendum InfoCons_Patients 18plus_Enregistrement_V1_1_200722 FR FR 1.1
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupA2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupB_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupC_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupD_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupE2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 13_15_GroupF_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 16plus_GroupA2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 16plus_GroupC_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 16plus_GroupE2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for 16plus_GroupF_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Age16plus_GroupB_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Age16plus_GroupD_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Parent_GroupB_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Parent_GroupC_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Parent_GroupD_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Parent_GroupE2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for Parent_GroupF_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS Info Sheet for ParentG_GroupA2_2IE ENRedacted 2
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Enregistrement_V3_1_200722 FR FR 3.1
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe A2_V3_0_181226 FR FR 3
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe B_V3_0_181226 FR FR 3
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe C_V3_0_181226 FR FR 3
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe D_V5_0_200722 FR FR 5
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe E2_V3_0_181226FR FR 3
Subject information and informed consent form (for publication) L1 PIS InfoCons_Mineurs 11to14_Groupe F_V3_0_181226FR FR 3
Subject information and informed consent form (for publication) L1 PIS Information Sheet for 13_15_Trial Entry_3 IE ENRedacted 3
Subject information and informed consent form (for publication) L1 PIS Information Sheet for ParentGuardian_GroupB_1PL PL 1
Subject information and informed consent form (for publication) L1 PIS Information Sheet for ParentGuardian_GroupC_1PL PL 1
Subject information and informed consent form (for publication) L1 PIS Information Sheet for ParentGuardian_GroupD_1PL PL 1
Subject information and informed consent form (for publication) L1 PIS Information Sheet for ParentGuardian_GroupE2_1PL PL 1
Subject information and informed consent form (for publication) L1 PIS Information Sheet for ParentGuardian_Trial Entry_3 IE ENRedacted 3
Subject information and informed consent form (for publication) L1 PIS Information Sheet for Patients 16yrplus_Trial Entry_3 IE ENRedacted 3
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe A JugendlATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe A Kinder ATAT 2
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe A_ElternATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe B JugendlATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe B KinderATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe B_ElternATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe C JugendlATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe C KinderATAT 2
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe C_ElternATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe D JugendlATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe D KinderATAT 3
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe D_ElternATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe E JugendlATAT 7
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe E Kinder ATAT 2
Subject information and informed consent form (for publication) L1 PIS_ICFMaster_Gruppe E_ElternATAT 7
Subject information and informed consent form (for publication) L1 PISICF 16plus Addendum A IE ENRedacted 1
Subject information and informed consent form (for publication) L1 PISICF A2 12-16 Jahre DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF A2 7-11 Jahre DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF A2 ab 17 Jahre DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF A2 Sorgeberechtigte DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF Adendum A_CI_Participacion en el Estudio_Pacientes mayores de 18 anos ES ES 1
Subject information and informed consent form (for publication) L1 PISICF Adendum A_CI_Participacion en el Estudio_Padres_Tutores ES ES 1
Subject information and informed consent form (for publication) L1 PISICF B 12-16 Jahre DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF B 7-11 Jahre DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF B ab 17 Jahre_DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF B SorgeberechtigteDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF C 12-16 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF C 7-11 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF C ab 17 Jahre_DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF C SorgeberechtigteDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Group B_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Group C_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Group D_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Group E2_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Group F_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 12-15yr_Trial Entry_v3 NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group A2_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group B_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group C_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group D_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group E2_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Group F_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Child 16yr ao_Trial Entry_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF D 12-16 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF D 7-11 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF D ab 17 Jahre_DE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF D SorgeberechtigteDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF E2 12-16 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF E2 7-11 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF F 12-16 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF F 7-11 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF F ab 17 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF F SorgeberechtigteDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF HIP_Participacion en el Estudio_Pacientes de 12 a 17 anos_V3 ES ES 3
Subject information and informed consent form (for publication) L1 PISICF HIP_Participacion en el Estudio_Pacientes mayores de 18 anos_V3 ES ES 3
Subject information and informed consent form (for publication) L1 PISICF HIP_Participacion en el Estudio_Padres-Tutores_V3 ES ES 3
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento A2 12-17 anos_v2 ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento A2 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento A2 padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento B 12-17 anos_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento B 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento B padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento C 12-17 anos_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento C 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento C padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento D 12-17 anos_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento D 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento D padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento E2 12-17 anos_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento E2 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento E2 padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento F 12-17 anos_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento F 18 anos o mas_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF HIP_Tratamiento F padres-tutores_v2ES ES 2
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12arGrBv1 NO NO 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12arGrCv1 NO NO 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12arGrDv1 NO NO 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12arGrE2v1 NO NO 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12arGrFv1_1 NO NO 1.1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivbarnunder12artrial entryv1_1 NO NO 1.1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivungdom12to16_18_GrBv1 NO NORedacted 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivungdom12to16_18_GrDv1 NO NORedacted 1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivungdom12to16_18_GrE2v1 NO NORedacted 1
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Subject information and informed consent form (for publication) L1 PISICF Infoskrivungdom12to16_18_trial entryv1_1NO NO 1.1
Subject information and informed consent form (for publication) L1 PISICF Infoskrivungdom12to16GrCpv1 NO NORedacted 1
Subject information and informed consent form (for publication) L1 PISICF Parents_Group A2_v3NL NLRedacted 3
Subject information and informed consent form (for publication) L1 PISICF Parents_Group B_v3NL NLRedacted 3
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Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre gruppe A2v1_1 NO NORedacted 1.1
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Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre gruppe Cv1_1NO NORedacted 1.1
Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre gruppe Dv1_1NO NORedacted 1.1
Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre gruppe E2v1_1NO NORedacted 1.1
Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre gruppe Fv1_2NO NORedacted 1.2
Subject information and informed consent form (for publication) L1 PISICF Samtykke foreldre trial entryv1_2NO NORedacted 1.2
Subject information and informed consent form (for publication) L1 PISICF Screening 12-16 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF Screening 7-11 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF Screening ab 17 JahreDE DERedacted 1.3
Subject information and informed consent form (for publication) L1 PISICF Screening SorgeberechtigteDE DERedacted 1.3
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Subject information and informed consent form (for publication) L1ICFInfoCons_Parents_Groupe C_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFInfoCons_Parents_Groupe D_V5_1_200722FRFR 5.1
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Subject information and informed consent form (for publication) L1ICFInfoCons_Parents_Groupe F_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFInfoCons_Patients 18plus_Enregistrement_V5_1_200722FRFR 5.1
Subject information and informed consent form (for publication) L1ICFInfoCons_Patients 18plus_Groupe A2_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFInfoCons_Patients 18plus_Groupe B_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFInfoCons_Patients 18plus_Groupe C_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFInfoCons_Patients 18plus_Groupe E2_V5_0_200107FRFR 5
Subject information and informed consent form (for publication) L1ICFPISIS_A2_12_14let_v3_17Oct2018 CZ CZ 3
Subject information and informed consent form (for publication) L1ICFPISStudy Entry_V3_20May2020BE EN 3
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Subject information and informed consent form (for publication) L1PIS_ICFMaster_Gruppe F_ElternATAT 7
Subject information and informed consent form (for publication) L1PIS_ICFMaster_Screen JugendlATAT 8
Subject information and informed consent form (for publication) L1PIS_ICFMaster_Screening Kinder ATAT 2
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Subject information and informed consent form (for publication) L1PISICFAdendum A_CI_Participacion en el Estudio_Pacientes de 12 a 17 anos ES ES 1
Subject information and informed consent form (for publication) L1PISICFAufklarung und Einverstandnis Biobank Eltern DE DERedacted 1.3
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Subject information and informed consent form (for publication) L1PISICFParentGuardian Addendum A IE ENRedacted 1
Subject information and informed consent form (for publication) N1Site_ContactListATEN 1
Subject information and informed consent form (for publication) Ouders_voogd_GroepA2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_GroepB_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_GroepC_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_GroepD_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_GroepE2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_GroepF_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Ouders_voogd_Studiedeelname_V3 20Mei2020 BE NL 3
Subject information and informed consent form (for publication) ParentsTuteurs_Groupe C_V1_2 15Nov2018 1.2
Subject information and informed consent form (for publication) Patient 12_17 jaar_GroepA2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 12_17 jaar_GroepB_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 12_17 jaar_GroupF_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 12_17 jaar- GroepD_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 12_17 jaar- Studiedeelname_V3 20Mei2020 BE NL 3
Subject information and informed consent form (for publication) Patient 12_17jaar_GroepE2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 12_17jaar- GroepC_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus jaar_Studiedeelname_V3 20Mei2020 BE NL 3
Subject information and informed consent form (for publication) Patient 18plus_GroepA2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus_GroepB_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus_GroepC_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus_GroepD_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus_GroepE2_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 18plus_GroepF_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) Patient 8-11 jaar_Studiedeelname_V1_2 15Nov2018 BE NL 1.2
Subject information and informed consent form (for publication) PHITT ICF E2 ab 17 Jahre_Redacted 1.3
Subject information and informed consent form (for publication) PHITT ICF E2 Sorgeberechtigte_Redacted 1.3
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCCAMPTO_20_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCCarboplatin_10mg_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCCisplatin_1mg_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCDoxorubicin_2mg_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCEtoposide_20mg_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCGemcitabine_100mg_ml_concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCNexavar_200mg_tabletsENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCOxaliplatin_5mgml_Concentrate_for_solutionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1 SMPCVinvristine Sulphate_1mg_ml injectionENEN 1
Summary of Product Characteristics (SmPC) (for publication) E1SMPCFluorouracil_50mg_ml_solution_for_injection_infusionENEN 1
Synopsis of the protocol (for publication) L1 SynopsisENEN3 3

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-15 Austria Acceptable
2025-01-21
 2025-01-21

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