metastatic colorectal cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

27 Jun 2025 → ongoing

Decision date (initial)

2024-05-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministère chargé de la santé/DGOS/PHRC-K 2021-AOK 21159

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Demonstrate an improvement of disease-free survival rate at 3 years

Secondary objectives 6

1. To compare the overall survival rates between the two treatment arms
2. To compare liver free survival between the two groups
3. To compare extra -hepatic recurrence rate between the two groups
4. To assess toxicity of postoperative treatment
5. To assess compliance of postoperative treatment
6. To assess the rate of further curative treatment of recurrence

Conditions and MedDRA coding

patient with colorectal cancer with hepatic metastasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer
2. No more than 10 treated CLM at surgery
3. At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy
4. Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery
5. R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
6. Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response
7. No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases
8. Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
9. No contraindication to FOLFIRI based chemotherapy
10. Patients must be 18 years old or older
11. A WHO performance status of 0 or 1
12. Participants must be affiliated to a social security scheme

Exclusion criteria 9

1. Palliative/R2 resection of CLM
2. 10 lesions or more treated at the time of surgery
3. Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy)
4. Extra-hepatic or residual metastasis of CRC
5. Absence of objective response to therapy (radiological or pathological response )
6. Inflammatory bowel disease
7. Known UGT1A1*28 allele homozygosity
8. Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone)
9. Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-free survival rate at 3 years

Secondary endpoints 6

1. Overall survival at 3 years
2. Liver-free survival at 3 years
3. Extra -hepatic recurrence rate
4. Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system
5. Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment
6. Rate of treatment of recurrence with curative intent

Investigational products

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

Test 4

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

PR Stéphane Benoist

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

PR Stéphane Benoist

Locations

1 EU/EEA country · 28 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 17 files

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

Application history

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