Recruiting nowPhase 3Randomised
What this trial is trying to do
The researchers are testing whether restarting FOLFIRI chemotherapy after surgery can remove or suppress microscopic colorectal cancer cells that remain after liver metastases have been removed. This applies to people whose liver metastases responded to preoperative FOLFIRI, with or without a targeted drug, and who could not receive oxaliplatin-based chemotherapy before surgery.
The comparison is postoperative FOLFIRI-based chemotherapy versus no postoperative treatment, which is the stated standard in this situation. The trial asks whether chemotherapy increases the proportion of people who remain free of detectable cancer three years after surgery, rather than measuring overall survival directly.
Worth knowing: This is an open-label trial, and its main outcome—three-year disease-free survival—measures recurrence-free time rather than whether people live longer overall.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06501482 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 254 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Assistance Publique – Hôpitaux de Paris |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Postoperative reintroduction of FOLFIRI based chemotherapy
What it is measuring
The disease-free survival rate
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: France.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06501482, registered by Assistance Publique – Hôpitaux de Paris on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.