FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases
Recruiting · NCT07467434 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Digestive Surgery Department, Bicêtre University Hospital AP-HP - Le Kremlin-Bicêtre, France