Clinical trial · Observational
FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases
Multicenter Cohort Study of Mid/Lower Rectal Cancer With Resectable Synchronous Liver Metastases Treated With FOLFIRINOX Induction Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antineoplastic Combined Chemotherapy Protocols | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgical Therapy | — | UNRESOLVED | — |
| Synchronous Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX
- description
- 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 outcomes (1)
- measure
- Curative resection rate of both tumor sites after induction chemotherapy with FOLFIRINOX
- timeFrame
- 18 months from the start of chemotherapy with FOLFIRINOX
- description
- 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.
Secondary outcomes (13)
- measure
- Overall 3-year survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available