Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- unresectable liver metastasis secondary to cancer of colon or rectum;
- scheduled for standard first line chemotherapy;
- ECOG performance score of 0 or 1;
- condition feasible for major abdominal surgery after first line treatment.
Exclusion
- diagnosis of metastatic disease \>3 months prior to study entry;
- evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
- prior systemic or local treatment of metastatic disease;
- prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
- history or evidence of CNS disease unrelated to cancer.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00778102
Start Date
October 1 2008
End Date
October 1 2013
Last Update
November 2 2016
Active Locations (19)
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1
Vienna, Austria, 1090
2
Bordeaux, France, 33075
3
Créteil, France, 94010
4
Le Mans, France, 72037