At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of colon or rectum with complete resection of primary tumor
- ✓Complete surgical resection (R0) of liver metastases 3–8 weeks before first study treatment
- ✓Metastases limited to liver only (no bone, lung, or brain metastases)
- ✕Prior hepatic radiation or surgical resection
- ✕Prior radiofrequency ablation or cryoablation of liver
- ✕Incomplete (non-R0) surgical resection of liver metastases
- ✕Prior chemotherapy for metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
In Brief
A Phase 3 clinical trial evaluating Irinotecan + 5 FU + folinic acid and Folinic Acid + 5 FU for Colorectal Neoplasms and Liver Neoplasms. Completed, enrolled 321 participants across 66 sites in 16 countries.
Detailed Summary
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
Study Details
Timeline
Interventions
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks