FOLFIRINOX Induction for Rectal Cancer with Synchronous Liver Mets
Official title: Multicenter Cohort Study of Mid/Lower Rectal Cancer With Resectable Synchronous Liver Metastases Treated With FOLFIRINOX Induction Chemotherapy
Run by Assistance Publique - Hôpitaux de Paris · NCT07467434 · Data updated 2026-11-12
This study tests whether giving at least two cycles of FOLFIRINOX before surgery helps treat both rectal cancer and liver metastases in adults with resectable disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 550 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Le Kremlin-Bicêtre) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | November 1, 2030 |
| Study ends | May 1, 2034 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07467434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with mid or low rectal adenocarcinoma (pMMR, T3-T4 and/or N+) and resectable synchronous liver metastases who have completed at least two cycles of induction FOLFIRINOX.
✕Probably not a fit
Patients with extrahepatic metastases, fewer than two cycles of induction FOLFIRINOX, or unresectable disease may not benefit from this observational approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SYNCHRONOX is an observational, multicenter study that first looks back and then follows a prospective cohort of up to 550 adults with mid- or low-rectal cancer and resectable synchronous liver metastases who receive induction FOLFIRINOX. The study aims to describe real-world treatment pathways and outcomes after induction chemotherapy, including the rate of complete removal of both tumor sites at 18 months and long-term survival metrics. It compares strategies such as simultaneous rectum and liver surgery, rectum-first, liver-first, and adaptive sequencing, to identify factors associated with curative treatment of both disease sites. All diagnostic and treatment decisions are made as part of routine care at participating centers. No interventional assignment is performed by the study protocol.
Why it matters
Potential benefit: If successful, patients could achieve higher rates of complete tumor removal and potentially improved survival with optimized sequencing of therapy.
How similar studies have gone: Previous observational studies in similar settings have provided insights into sequencing approaches, though this exact protocol combining retrospective and prospective cohorts is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects aged 18 years and older * Adenocarcinoma of the middle and/or lower rectum pMMR T3, T4, and/or N+ * Resectable synchronous liver metastases Exclusion Criteria: * Minor under the age of 18. * Presence of extrahepatic metastases * Induction chemotherapy with FOLFIRINOX of less than 2 courses
Where it's running
-
Digestive Surgery Department, Bicêtre University Hospital AP-HP
Le Kremlin-Bicêtre, France Recruiting
Study contacts
- Study coordinator: Stéphane BENOIST, MD PhD
- Email: stephane.benoist@aphp.fr
- Phone: +33 (0)1 45 21 34 72
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.