Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
712
Countries
10
Sites
57
Recurrent and Primary Refractory Ewing Sarcoma
The objectives of the study are to compare systemic anti-cancer therapy regimens in recurrent/refractory ES in order to identify the best one with respect to efficacy (imaging response and survival), toxicity and acceptability to patients.
Key facts
- Sponsor
- The University Of Birmingham
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 May 2015 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- AAMU Suomen Lasten Syöpäsäätiö · Bone Cancer Research Trust · Børnecancerfonden (The Danish Childhood Cancer Foundation) · Cancer Research UK · European Commission · Skane Lans Landsting Adr (SSG) · St. Anna Children`s Cancer research Insitute
External identifiers
- EU CT number
- 2024-516078-31-00
- EudraCT number
- 2014-000259-99
- ISRCTN
- ISRCTN36453794
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
The objectives of the study are to compare systemic anti-cancer therapy regimens in recurrent/refractory ES in order to identify the best one with respect to efficacy (imaging response and survival), toxicity and acceptability to patients.
Conditions and MedDRA coding
Recurrent and Primary Refractory Ewing Sarcoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10015563 | Ewing's sarcoma NOS | 10029104 |
| 27.0 | PT | 10015562 | Ewing´s sarcoma metastatic | 100000004864 |
| 21.1 | LLT | 10015763 | Extra-osseous Ewing's sarcoma NOS | 10029104 |
| 20.0 | PT | 10015564 | Ewing's sarcoma recurrent | 100000004864 |
| 27.0 | PT | 10015761 | Extra-osseous Ewing´s sarcoma metastatic | 100000004864 |
| 27.0 | LLT | 10015569 | Ewing´s tumor recurrent | 10029104 |
| 27.0 | LLT | 10015567 | Ewing´s tumor localized | 10029104 |
| 27.0 | LLT | 10058252 | Ewing´s tumour recurrent | 10029104 |
| 27.0 | LLT | 10015566 | Ewing´s tumor | 10029104 |
| 27.0 | LLT | 10015762 | Extra-osseous Ewing´s sarcoma non-metastatic | 10029104 |
| 20.0 | LLT | 10015570 | Ewing's tumour | 10029104 |
| 20.0 | PT | 10015560 | Ewing's sarcoma | 100000004864 |
| 21.1 | PT | 10015759 | Extra-osseous Ewing's sarcoma | 100000004864 |
| 27.0 | LLT | 10058254 | Ewing´s tumour localised | 10029104 |
| 27.0 | LLT | 10015568 | Ewing´s tumor metastatic | 10029104 |
| 21.1 | PT | 10015764 | Extra-osseous Ewing's sarcoma recurrent | 100000004864 |
| 27.0 | LLT | 10058253 | Ewing´s tumour metastatic | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.
- Written informed consent from the patient and/or parent/legal guardian.
- Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
- Age ≥ 2 years (* Trial sites in Austria will only recruit patients aged ≥2 years<30 years due to the conditional approval issued by their ethics committee).
- Eligible for randomisation between at least two open study arms.
- Adequate renal function defined as GFR ≥60 ml/min/1.73m2. If GFR is calculated and is <90 ml/min/1.73m2, an isotopic GFR should be performed to confirm adequate renal function.
- Patient assessed as medically fit to receive trial treatment.
- Date of planned randomisation within 4 weeks of baseline imaging.
- Documented negative pregnancy test for female patients of childbearing potential.
- Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
- For IFOS/IFOS-L randomisation only: Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN.
- For IFOS/IFOS-L randomisation only: Left ventricular ejection fraction ≥50% at baseline as determined by echocardiography.
- For IFOS/IFOS-L randomisation only: Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: a. BP <95th percentile for sex, age, and height. Subjects >18 years of age should have BP ≤150/90 mm Hg at screening.
- For IFOS/IFOS-L randomisation only: Urine dipstick <2+ for proteinuria. If ≥2+ proteinuria on dipstick, a spot urine protein:creatinine ratio test must be < CTCAE grade 2 Proteinuria.
Exclusion criteria 20
- Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.
- Clinical evidence of nephrotic syndrome.
- Follow-up not possible due to social, geographic or psychological reasons.
- Previous randomisation into the rEECur trial.
- Patients with a contraindication or hypersensitivity to any IMP may not be randomised to receive an arm that contains the contraindicated IMP.
- Patients who have previously received one of the trial regimens off-trial may not be randomised to receive that regimen again. Patients who have had ifosfamide during first line therapy may receive the IFOS or IFOS-L arm. There is no requirement for a minimum time between receiving first line ifosfamide and entry to rEECur.
- Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.
- Radiotherapy to target lesion within previous six weeks.
- Pregnant or breastfeeding women.
- Pre-existing medical condition that would necessitate a dose modification during cycle 1 as described in section 7 of the protocol.
- Any central neurotoxicity with previous ifosfamide treatment.
- For CE randomisation only: Carboplatin is contraindicated in patients with actively bleeding tumours. Therefore, patients with actively bleeding tumours are not eligible for the CE randomisation.
- For IFOS/IFOS-L randomisation only: Clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec).
- For IFOS/IFOS-L randomisation only: History of aneurysm.
- For IFOS/IFOS-L randomisation only: Arterial Thromboembolism in previous 6 months.
- For IFOS/IFOS-L randomisation only: Gastrointestinal or non-gastrointestinal fistula.
- For IFOS/IFOS-L randomisation only: Gastrointestinal bleeding or active haemoptysis within previous 3 weeks.
- For IFOS/IFOS-L randomisation only: Major surgery within previous 3 weeks.
- For IFOS/IFOS-L randomisation only: Previous treatment with tyrosine kinase inhibitors.
- For IFOS/IFOS-L randomisation only: Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel, or proximity to major blood vessels with potential risk of severe haemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event-free survival time (EFS)
Secondary endpoints 7
- Objective imaging response (OR) according to RECIST 1.1 criteria after 2, 4, and 6 cycles for CE and after 2 and 4 cycles for IFOS and IFOS-L, and at the end of trial treatment for all arms
- Progression-free survival time (PFS)
- Overall survival time (OS)
- Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (see Appendix 2 of protocol)
- PET-CT response after 4 cycles
- Quality of life (QoL)
- Days spent in hospital
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 19
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square 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
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 900 mg/m2 milligram(s)/square meter
- Max total dose
- 10800 mg/m2 milligram(s)/square 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
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 900 mg/m2 milligram(s)/square meter
- Max total dose
- 10800 mg/m2 milligram(s)/square 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
SUB11191MIG · Substance
- Active substance
- Topotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0.75 mg/m2 milligram(s)/square meter
- Max total dose
- 22.5 mg/m2 milligram(s)/square 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
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 2400 mg/m2 milligram(s)/square 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
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 mg/m2 milligram(s)/square meter
- Max total dose
- 7500 mg/m2 milligram(s)/square 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
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 120 mg/m2 milligram(s)/square meter
- Max total dose
- 2160 mg/m2 milligram(s)/square 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
SUB13772MIG · Substance
- Active substance
- Etoposide Phosphate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 136.32 mg/m2 milligram(s)/square meter
- Max total dose
- 2453.76 mg/m2 milligram(s)/square 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
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 50 mg/m2 milligram(s)/square meter
- Max total dose
- 1500 mg/m2 milligram(s)/square 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
SUB08125MIG · Substance
- Active substance
- Ifosfamide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 gm/m2 gram(s)/square meter
- Max total dose
- 60 gm/m2 gram(s)/square 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
PRD2958373 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 17520 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX08 — -
- Marketing authorisation
- EU/1/15/1002/001
- MA holder
- EISAI GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Modified in clinical livery (different markings on the capsule and used in different indications. The safety and efficacy of lenvatinib in the paediatric/adult population in the indication of relapse and refractory Ewing Sarcoma (ES) is not within the current licensed indication).
PRD2958374 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 17520 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX08 — -
- Marketing authorisation
- EU/1/15/1002/002
- MA holder
- EISAI GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Modified in clinical livery (different markings on the capsule and used in different indications. The safety and efficacy of lenvatinib in the paediatric/adult population in the indication of relapse and refractory Ewing Sarcoma (ES) is not within the current licensed indication).
SUB22289 · Substance
- Active substance
- Anhydrous Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 80 mg/m2 milligram(s)/square meter
- Max total dose
- 480 mg/m2 milligram(s)/square 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
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 80 mg/m2 milligram(s)/square meter
- Max total dose
- 480 mg/m2 milligram(s)/square 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
The University Of Birmingham
- 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
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
| St James's University Hospital ORG-100031074
|
Leeds, United Kingdom | Other, Laboratory analysis |
| The Christie NHS Foundation Trust ORG-100009776
|
Manchester, United Kingdom | Other, Laboratory analysis |
Locations
10 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 10 | 5 |
| Belgium | Ongoing, recruiting | 8 | 1 |
| Czechia | Ongoing, recruiting | 7 | 1 |
| Denmark | Ongoing, recruiting | 20 | 4 |
| Finland | Ongoing, recruiting | 20 | 5 |
| France | Ongoing, recruiting | 88 | 7 |
| Italy | Ongoing, recruiting | 102 | 10 |
| Netherlands | Ongoing, recruiting | 11 | 2 |
| Norway | Ongoing, recruiting | 20 | 4 |
| Spain | Ongoing, recruiting | 150 | 18 |
| Rest of world
United Kingdom, Australia, New Zealand, Switzerland
|
— | 276 | — |
Investigational sites
Medical University Of Graz
Klinische Abteilung für Pädiatrische Hämatologie/Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Johannes Kepler University Linz
Med Campus IV, Krankenhausstrasse 26-30, 4020, Linz
St. Anna Kinderspital GmbH
Hämato/Onkologie, Kinderspitalgasse 6, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Pädiatrie I Department für Kinder- und Jugendheilkunde, Anichstrasse 35, 6020, Innsbruck
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Kinderspital / Abteilung für Kinderund Jugendheilkunde, Muellner Hauptstrasse 48, 5020, Salzburg
Cliniques Universitaires Saint-Luc
Hematologie Pediatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Fakultni Nemocnice V Motole
Department of Oncology and Radiotherapy, V Uvalu 84/1, Motol, Prague
Rigshospitalet
Department of Paediatrics and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Region Hovedstaden
Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Region Midtjylland
Department of Paediatrics and Adolescent Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Midtjylland
Department of Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
University Of Oulu
Pediatrics, P. O. Box 23, 90029, Oulu
HUS-Yhtymae
Ped hem-onc, Stenbackinkatu 9, 00290, Helsinki
HUS-Yhtymae
Cancer Center, Haartmaninkatu 4, 00290, Helsinki
Varsinais-Suomen hyvinvointialue
Pediatrics, Kiinamyllynkatu 4-8, 20520, Turku
Pirkanmaan hyvinvointialue
Peditrics, Elamanaukio 2, 33520, Tampere
Assistance Publique Hopitaux De Paris
Service d'Hématologie et oncologie pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Institut Gustave Roussy
nt de cancérologie de l’enfant et l’adolescent, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Hopital Des Enfants
Pediatric oncology, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier Regional De Marseille
Service d’immunologie, hématologie et oncologie pédiatrique, 264 Rue Saint Pierre, 13005, Marseille
Centre Leon Berard
Paediatric oncology, 28 Rue Laennec, 69008, Lyon
CHU Besancon
Hématologie oncologie pédiatrique, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Les Hopitaux Universitaires De Strasbourg
Onco-hématologie pédiatrique, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Istituto Ortopedico Rizzoli
SC Osteoncology Unit, Via Di Barbiano 1/10, 40136, Bologna
Azienda Ospedaliero Universitaria Pisana
Pediatric Onco-Hematology Unit, Via Roma 67, 56126, Pisa
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Sarcomi e Tumori Rari, Via Elio Chianesi N 53, 00144, Rome
Ospedale Pediatrico Bambino Gesu
Dipartimento di Oncoematologia e Terapia, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Ospedaliera di Padova
UOC Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Meyer IRCCS
Dipartimento di Oncoematologia Pediatrica e Cure Domiciliari, Viale Gaetano Pieraccini 24, 50139, Florence
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC Oncologia Medica dei Tumori Mesenchimali dell’Adulto, Via Giacomo Venezian 1, 20133, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC pediatria Oncologica, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC oncoematologia pediatrica, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Santobono Pausilipon
Department of Oncology, Hematology and Cell Therapies, Via Posillipo 226, 80123, Naples
Radboud universitair medisch centrum Stichting
Department of Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Prinses Maxima Centrum voor Kinderoncologie B.V.
Solid Tumours, Heidelberglaan 25, 3584 CS, Utrecht
Oslo University Hospital HF
Oncology Department, Taarnbygget, Kirkeveien 166, Oslo
Universitetssykehuset Nord-Norge HF
Department of Oncology, Sykehusvegen 38, 9019, Tromsoe
Helse Bergen HF
Department of Oncology, Haukelandsveien 22, 5021, Bergen
St. Olavs Hospital HF
Oncology department, P. O. Box 3250, Torgarden, Trondheim
Hospital Universitario La Paz
Medical Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Regional De Malaga
Paediatric Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Miguel Servet
Medical Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Central De Asturias
Medical Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De Cruces
Medical Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos S/N, 29010, Malaga
Hospital Universitario De Canarias
Medical Oncology, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital De La Santa Creu I Sant Pau
Medical Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Sant Joan De Deu Barcelona
Paediatric Oncology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Infantil Universitario Nino Jesus
Medical Oncology, Avenida Menendez Pelayo 65, 28009, Madrid
University Hospital Son Espases
Medical Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-02-05 | 2023-01-10 | |||
| Belgium | 2016-06-13 | 2017-06-09 | |||
| Czechia | 2016-09-30 | 2017-11-24 | |||
| Denmark | 2015-09-01 | 2016-01-19 | |||
| Finland | 2015-08-03 | 2018-08-22 | |||
| France | 2016-01-08 | 2016-03-30 | |||
| Italy | 2015-07-28 | 2015-10-01 | |||
| Netherlands | 2017-12-15 | 2017-12-18 | |||
| Norway | 2015-07-21 | 2016-02-23 | |||
| Spain | 2015-05-05 | 2015-07-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 105 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Consolidated Protocol EN Public | 7.0a |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements AT EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements BE EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements CZ EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements ES EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements FR EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements IT EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitmment Arrangements DK EN | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitmment Arrangements FI FI | 1 |
| Recruitment arrangements (for publication) | K1 Recruitmment Arrangements NL EN | 1 |
| Recruitment arrangements (for publication) | K1 Recruitmment Arrangements NO EN | 1 |
| Subject information and informed consent form (for publication) | L1 Fact sheet summary Adults | 6 |
| Subject information and informed consent form (for publication) | L1 Fact sheet summary Guardian | 6 |
| Subject information and informed consent form (for publication) | L1 ICF Centre-specific contact details AT DE Public | 2 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adolescent 15-17 FI FI Public | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adolescent Patients AT DE Public | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adult AT DE Public | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adult FI FI Public | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adults | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Adults over 16 ES ES Public | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children 12-14 FI FI Public | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children 12-15 ES ES Public | 8 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children 12-17 IT IT | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children AT DE | 4 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children under 11 IT IT | 5 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Children under 12 FI FI Public | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS for personal, special and genetic data Adults and Guardians | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Guardian | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Guardian FI FI Public | 1 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Of legal age AT DE Public | 3 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Parent & Guardian AT DE Public | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Parent-Guardian ES ES Public | 7 |
| Subject information and informed consent form (for publication) | L1 ICF & PIS Pregnancy ES ES Public | 4 |
| Subject information and informed consent form (for publication) | L1 ICF Adults BE FR | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Adults BE NL | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Adults CZ CS | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Adults FR FR | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Adults NL NL | 1.0 |
| Subject information and informed consent form (for publication) | L1 ICF Guardians FR FR | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Guardians BE FR | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Guardians BE NL | 2 |
| Subject information and informed consent form (for publication) | L1 ICF Parents NL NL | 1.0 |
| Subject information and informed consent form (for publication) | L1 ICF Patients 12-15 years NL NL | 1.0 |
| Subject information and informed consent form (for publication) | L1 PIS Adults FR FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Children 8-12 FR FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Adults NO NO Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Adults addendum 2 FR FR | 1 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Adults addendum C FR FR | 1 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Adults addendum FR FR | 1 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Guardians addendum 2 FR FR | 1 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Guardians addendum FR FR | 1 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Parents NO NO Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Patients 12-15 years NO NO | 4.0 |
| Subject information and informed consent form (for publication) | L1 PIS & ICF Patients 8-11 years NO NO | 4.0 |
| Subject information and informed consent form (for publication) | L1 PIS Addendum 1 CZ CS | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Addendum 2 CZ CS | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adolescent Patients DK DA Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum 1 BE NL Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum 1 BE FR Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum 2 BE FR Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum 2 BE NL Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum 2 NL NL | 1. |
| Subject information and informed consent form (for publication) | L1 PIS Adults addendum NL NL | 1.0 |
| Subject information and informed consent form (for publication) | L1 PIS Adults BE FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Adults BE NL | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Adults CZ CS | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Adults DK DA | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Adults NL NL Public | 5.0 |
| Subject information and informed consent form (for publication) | L1 PIS Adults Summary BE FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Adults Summary BE NL | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Children 13-17 BE FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Children 13-17 BE NL | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Children 13-17 FR FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Children 8-12 BE FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Children 8-12 BE NL | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians FR FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians addendum 1 BE FR Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians addendum 1 BE NL Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians addendum 2 BE FR Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians addendum 2 BE NL Public | 1 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians BE FR | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians BE NL | 3 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians Summary BE FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Guardians Summary BE NL | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Parents NL NL Public | 5.0 |
| Subject information and informed consent form (for publication) | L1 PIS Patients 12-15 years NL NL | 5.0 |
| Subject information and informed consent form (for publication) | L1 PIS Patients 8-11 years NL NL | 5.0 |
| Subject information and informed consent form (for publication) | L1 PIS Summary Adults CZ CS | 2 |
| Subject information and informed consent form (for publication) | L1 PIS Summary Adults FR FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS summary Adults NL NL | 2.0 |
| Subject information and informed consent form (for publication) | L1 PIS Summary Guardians FR FR | 2 |
| Subject information and informed consent form (for publication) | L1 PIS summary Parents NL NL | 2.0 |
| Subject information and informed consent form (for publication) | L1 Sub-study ICF and PIS Adults IT IT | 1 |
| Subject information and informed consent form (for publication) | L1 Sub-study ICF and PIS Guardian IT IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Carboplatin EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Cycloposphamide EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Docetaxel EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Etopophos EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Etoposide EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Gemcitabine EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Ifosfamide EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Irinotecan EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Lenvatinib EN | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Temozolomide EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Topotecan EN | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Denmark | Acceptable 2024-11-29
|
2024-11-29 |