NCT00143403

Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	Irinotecan + 5 FU + folinic acid	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
DRUG	Folinic Acid + 5 FU	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

Timeline

• Start date: 2001-12-01
• Primary completion: 2008-02-01
• Completion: 2009-09-01
• First posted: 2005-09-02
• Last updated: 2010-09-28
• Results posted: 2009-06-01

Locations

66 sites across 16 countries: Belgium, Denmark, France, Germany, Hong Kong, Israel, Italy, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom