Status:
COMPLETED
OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in pat...
Eligibility Criteria
Inclusion
- adult patients, 18-70 years of age;
- metastatic colorectal cancer scheduled for standard first line chemotherapy;
- at least 1 measurable lesion;
- ECOG performance score of 0 or 1.
Exclusion
- prior chemotherapy for metastatic colorectal cancer;
- prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
- concomitant malignancies other CRC;
- history or evidence of CNS disease unrelated to cancer.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00940303
Start Date
June 1 2009
End Date
February 1 2014
Last Update
November 2 2016
Active Locations (17)
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1
Berlin, Germany, 10117
2
Berlin, Germany, 13347
3
Bochum, Germany, 44791
4
Celle, Germany, 29221