FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07467434
Status
Recruiting
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Conditions

  • Antineoplastic Combined Chemotherapy Protocols
  • Rectal Cancer
  • Surgical Therapy
  • Synchronous Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Mar 12, 2026
Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2030
Completion
May 1, 2034

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Patients with rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX
    Follow-up as part of the usual care of patients with mid/lower rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX induction chemotherapy.

Primary Outcome Measure

Curative resection rate of both tumor sites after induction chemotherapy with FOLFIRINOX [ Time Frame: 18 months from the start of chemotherapy with FOLFIRINOX ]

Central Contacts

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