Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
358
Countries
2
Sites
9
Resectable peritoneal metastases of a colorectal origin
The primary objectives of the phase II study are to explore the feasibility of accrual, and the feasibility, safety, and tolerance of perioperative systemic therapy. The primary objective of the phase III study is to compare overall survival between both arms.
Key facts
- Sponsor
- Catharina Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-11-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518570-13-00
- EudraCT number
- 2016-001865-99
- ClinicalTrials.gov
- NCT02758951
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
The primary objectives of the phase II study are to explore the feasibility of accrual, and the feasibility, safety, and tolerance of perioperative systemic therapy.
The primary objective of the phase III study is to compare overall survival between both arms.
Conditions and MedDRA coding
Resectable peritoneal metastases of a colorectal origin
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- ▪ a World Health Organisation (WHO) performance status of ≤1; ▪ histological or cytological proof of PM of a non-appendiceal colorectal adenocarcinoma with ≤50% of the tumour cells being signet ring cells; ▪ resectable disease determined by a diagnostic laparoscopy/laparotomy in combination with abdominal computed tomography and/or magnetic resonance imaging (MRI); only in patients in whom diagnostic laparoscopy or laparotomy is considered not feasible or valuable (e.g. due to known adhesions impeding adequate PCI scoring), it is also allowed to determine resectability by CT or MRI only (provided that the colorectal PM are histologically or cytologically proven); ▪ no evidence of systemic colorectal metastases within three months prior to enrolment; ▪ no systemic therapy for colorectal cancer within six months prior to enrolment; ▪ no contraindications for CRS-HIPEC; ▪ no previous CRS-HIPEC; ▪ no concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal PM.
Exclusion criteria 1
- ▪ Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin <6.0 mmol/L, neutrophils <1.5 x 109/L, platelets <100 x 109/L, serum creatinine >1.5 x ULN, creatinine clearance <30 ml/min, bilirubin >2 x ULN, serum liver transaminases >5 x ULN); ▪ Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan, to such extent that the oncologist does not consider the patient eligible for systemic therapy; ▪ Serious active infections; ▪ Severe diarrhoea; ▪ Stomatitis or ulceration in the mouth or gastrointestinal tract; ▪ Recent major cardiovascular events; ▪ Unstable or uncompensated respiratory or cardiac disease; ▪ Bleeding diathesis or coagulopathy; ▪ Pregnancy or lactation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To determine the difference between both treatments in terms of overall survival (calculated from the interval from diagnosis of peritoneal metastases until death or last follow-up).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
IRINOTECAN MYLAN GENERICS 20 mg/ml concentrato per soluzione per infusione
PRD437027 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 180 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1080 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — -
- Marketing authorisation
- 038804098
- MA holder
- MYLAN S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7.5 mg/Kg milligram(s)/kilogram
- Max total dose
- 22.5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
5-Fluorouracil Sandoz 50 mg/ml koncentrátum oldatos infúzióhoz
PRD5801880 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 16800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- OGYI-T-7514/01
- MA holder
- SANDOZ HUNGÁRIA KFT
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Leucovorin-Teva 10 mg/ml Concentrate for Solution for Infusion
PRD702326 · Product
- Active substance
- Folinic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- PA 749/1/1
- MA holder
- TEVA PHARMA B.V.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xeloda 150 mg film-coated tablets
PRD9863933 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- EU/1/00/163/001
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie
PRD10195501 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 130 mg/m2 milligram(s)/sq. meter
- Max total dose
- 520 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- BE661053
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Catharina Ziekenhuis Stichting
- Sponsor organisation
- Catharina Ziekenhuis Stichting
- Address
- Michelangelolaan 2
- City
- Eindhoven
- Postcode
- 5623 EJ
- Country
- Netherlands
Scientific contact point
- Organisation
- Catharina Ziekenhuis Stichting
- Contact name
- Ignace De Hingh
Public contact point
- Organisation
- Catharina Ziekenhuis Stichting
- Contact name
- Ignace De Hingh
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 5 | 1 |
| Netherlands | Authorised, recruitment pending | 353 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum Stichting
Surgery, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Surgery, Plesmanlaan 121, 1066 CX, Amsterdam
Academisch Medisch Centrum
Surgery, Meibergdreef 9, 1105 AZ, Amsterdam
Catharina Ziekenhuis Stichting
Surgery, Michelangelolaan 2, 5623 EJ, Eindhoven
Sint Antonius Ziekenhuis Stichting
Surgery, Koekoekslaan 1, 3435 CM, Nieuwegein
Universitair Medisch Centrum Utrecht
Surgery, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Surgery, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
Universitair Medisch Centrum Groningen
Surgery, Hanzeplein 1, 9713 GZ, Groningen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Consolidated Protocol_2024-518570-13-01 | 1 |
| Recruitment arrangements (for publication) | null | 1 |
| Recruitment arrangements (for publication) | null | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518570-13 | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518570-13 | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_5-Fluorouracil_2024-518570-13 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bevacizumab_2024-518570-13 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Capecitabine_2024-518570-13 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan_2024-518570-13 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Leucovorin_2024-518570-13 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxaliplatin_2024-518570-13 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518570-13 | 1 |
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 | Netherlands | Acceptable 2024-11-12
|
2024-11-12 |