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.
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
Minor under the age of 18.
Presence of extrahepatic metastases
Induction chemotherapy with FOLFIRINOX of less than 2 courses
Patients with mid/lower rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX induction chemotherapy
Cohort
Other
Not listed
Curative resection rate of both tumor sites after induction chemotherapy with FOLFIRINOX
For rectal cancer, resection is considered curative in cases of R0 resection (distal margin ≥ 1 cm and circumferential resection margin \> 1 mm). Non-surgical organ preservation is also considered curative treatment in cases of complete clinical response not followed by tumor regrowth during the first year. For liver metastases, resection is considered curative if all visible lesions have been resected R0 (resection margin \> 1 mm) or destroyed by radiofrequency.
Overall 3-year survival rate
The length of time from the start of FOLFIRINOX chemotherapy until death.
Three-year progression-free survival rate
Survival is calculated from the start of treatment with FOLFIRINOX chemotherapy. Any progression during preoperative treatment preventing complete resection for curative purposes, the discovery of a contraindication to surgery during the operation, and the occurrence of recurrence after surgery will be considered an event.
Complete resection rate (R0) of rectal tumors
Resection is considered complete (R0) if the distal margin is ≥ 1 cm and the circumferential resection margin is \> 1 mm.
Complete resection rate (R0) of liver lesions
Resection is considered complete (R0) if the resection margin is \> 1 mm.
Click on the lead sponsor to view all of their trials.
