Status:
COMPLETED
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Liver Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- Prior hepatic radiation or resection.
- Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
- Prior chemotherapy for metastatic disease.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00143403
Start Date
December 1 2001
End Date
September 1 2009
Last Update
September 28 2010
Active Locations (66)
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1
Pfizer Investigational Site
Ghent, Belgium, 9000
2
Pfizer Investigational Site
Roeselare, Belgium, 8800
3
Pfizer Investigational Site
Copenhagen, Denmark, 2100
4
Pfizer Investigational Site
Herlev, Denmark, DK-2730