RecruitingPhase 3NCT06501482

Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI

"Interest of Postoperative Reintroduction of Chemotherapy in Patients Undergoing Resection of Colorectal Liver Metastases After Good Response to FOLFIRI-based Chemotherapy With or Without Targeted Agent" (Intergroup FRENCH- PRODIGE)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

254 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Liver Metastases

Summary

Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents. These patients must have objective response to treatment (radiologic or pathologic response). The standard care for these patients is no postoperative treatment although benefit of reintroduction of FOLFIRI chemotherapy in good responders could be expected. This study is a National, multicenter, open-label randomized, 2-arm, phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy (experimental arm) vs no treatment (control arm) in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent. The primary endpoint of the study is 3-year disease free survival. Based on published data, 3-year DFS in control group (absence of postoperative treatment is 25%. Expected 3-year DFS in the experimental group is 40%. The study will randomize 254 patients (127 in the chemotherapy group and 127 in the no treatment group) in 30 french academic centers.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a chemotherapy regimen called FOLFIRI after surgery (as adjuvant treatment) helps prevent colorectal liver metastases from coming back, in patients whose liver metastases responded well to this same chemotherapy before surgery. **You may be eligible if...** - You have colorectal cancer that spread to the liver (liver metastases) appearing more than 12 months after the original colon cancer was treated - Your liver metastases were surgically removed with the goal of cure (no more than 10 metastases) - You received 2–8 cycles of FOLFIRI-based chemotherapy before surgery, and your cancer responded (shrank or showed pathologic improvement) - No cancer remains outside the liver after surgery - You are 18 or older with good overall health (WHO performance status 0–1) - Your RAS and BRAF gene status has been tested **You may NOT be eligible if...** - The surgery was not fully removing all cancer (palliative surgery) - You have cancer outside the liver (except a single small non-specific lung nodule) - Your cancer did not respond to pre-surgery FOLFIRI chemotherapy - You have inflammatory bowel disease - You have known genetic variants that make it hard to tolerate FOLFIRI (UGT1A1 or DPD deficiency) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPostoperative reintroduction of FOLFIRI based chemotherapy

Postoperative reintroduction of FOLFIRI: irinotecan 180 mg/m2 + leucovorin 400 mg/m2 at day 1 then 5-FU 400 mg/m2 bolus followed by 2400 mg/m2 continuous infusion over 46 h biweekly. For a total of 12 cycles of perioperative chemotherapy including the preoperative chemotherapy