Adjuvant FOLFIRI after surgery for colorectal liver metastases that responded to preoperative FOLFIRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a national, multicenter, open-label, randomized phase III trial comparing postoperative reintroduction of FOLFIRI-based chemotherapy versus no postoperative treatment in patients who had resection of colorectal liver metastases after responding to preoperative FOLFIRI (with or without targeted agents). Eligible patients have metachronous liver-only disease (≤10 metastases), received 2–8 cycles of preoperative FOLFIRI, achieved an objective radiologic or pathologic response, and had curative-intent R0/R1 resection within 12 weeks of chemotherapy. Patients are randomized to receive adjuvant FOLFIRI or observation, and the primary endpoint is 3-year disease-free survival. The trial is sponsored by Assistance Publique - Hôpitaux de Paris and conducted at participating centers in France, with Hôpital Kremlin Bicêtre listed as a lead site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* No more than 10 treated CLM at surgery
* At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy.
* Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery
* R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
* Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response or stable desease
* 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
* Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
* No contraindication to FOLFIRI based chemotherapy
* Patients must be 18 years old or older
* A WHO performance status of 0 or 1
* Participants must be affiliated to a social security scheme

Exclusion Criteria:

* Palliative/R2 resection of CLM
* 10 lesions or more treated at the time of surgery
* Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy)
* Extra-hepatic or residual metastasis of CRC
* Absence of objective response to therapy (radiological or pathological response )
* Inflammatory bowel disease
* Known UGT1A1\*28 allele homozygosity
* complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml
* Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone)
* Persistent toxicity ≥ grade 1 related to preoperative FOLFIRI based chemotherapy
* Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women

Where it's running

• Hôpital Kremlin Bicêtre
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Eric VICAUT, MHD, PHD — Aphp
• Study coordinator: Stéphane BENOIST, MHD, PHD
• Email: Stephane.benoist@aphp.fr
• Phone: 33 1 45 21 34 72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.