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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed 18 to 75 Pharmaceutical / Industry CPT-GMA-301
A5961076, NCT00143403

Trial Description

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00143403
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.