FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases

Recruiting now

Conditions studied: Rectal Cancer, Synchronous Liver Metastases, Antineoplastic Combined Chemotherapy Protocols, Surgical Therapy

In brief

SYNCHRONOX is a multicenter cohort (retrospective then prospective) intending to include 550 patients with mid or low rectal adenocarcinoma (pMMR, T3-T4 and/or N+) and resectable synchronous liver metastases, treated upfront with at least two cycles of induction FOLFIRINOX chemotherapy. The primary objective is to determine, at 18 months, the R0 resection rate of both tumor sites (rectum and liver), while secondary objectives focus on 3 year overall and progression free survival, radiological and pathological responses, postoperative morbidity and mortality, and comparison of the different surgical strategies after FOLFIRINOX.

Key facts

Study ID

NCT07467434

Run by

Assistance Publique - Hôpitaux de Paris

People needed

550

Starts

2026-05-01

Expected to finish

2034-05-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Minor under the age of 18.
• Presence of extrahepatic metastases
• Induction chemotherapy with FOLFIRINOX of less than 2 courses

Where it is running

• Digestive Surgery Department, Bicêtre University Hospital AP-HP — Le Kremlin-Bicêtre, France (enrolling)

Full record on ClinicalTrials.gov

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