An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
- 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.
- 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.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Time Frame:
assessed every 8 weeks up to week 102, 3-monthly during follow-up
- Colorectal Cancer
- Colorectal Neoplasms