About this trial

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

Qualifiers

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

Disqualifiers

Minor under the age of 18.

Presence of extrahepatic metastases

Induction chemotherapy with FOLFIRINOX of less than 2 courses

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

550 Participants
are grouped into 1 trial group

Locations

1
Digestive Surgery Department, Bicêtre University Hospital AP-HP94270, Le Kremlin-Bicêtre France

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor