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

Phase 3

Completed

• Conditions: Colorectal Neoplasms; Liver Neoplasms
• Interventions: Drug: Irinotecan + 5 FU + folinic acid; Drug: Folinic Acid + 5 FU

• Registration Number: NCT00143403
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2008-02
• Results First Submitted: 2009-02-26
• Results First Submitted QC: 2009-04-11
• Results First Posted: 2009-06-01
• Study Completion: 2009-09
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
• Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
• Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

Exclusion Criteria

• Prior hepatic radiation or resection.
• Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
• Prior chemotherapy for metastatic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Irinotecan + 5 FU + folinic acid	-
2	Folinic Acid + 5 FU	-

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	last tumor assessment date or cut-off date, whichever is earlier.	time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Rates	Median follow-up time (42 months)	Probability of being alive was calculated in a yearly increment.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Surrey, United Kingdom