FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases

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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 550

Sponsor: Assistance Publique - Hôpitaux de Paris

Location: Digestive Surgery Department, Bicêtre University Hospital AP-HP Le Kremlin-Bicêtre

Summary

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.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07467434). StuddyBuddy aggregates publicly available trial information.