- Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with
alternating Xeliri and Xelox as first-line treatment of patients with metastatic
colorectal cancer.
- Primary objective: PFS, To assess overall resectability in patients with metastatic
colorectal cancer, postoperative morbidity and outcomes after resection.
- Secondary objectives: To assess response rates according to RECIST criteria, failure
free survival (TTF) and overall survival (OS), Quality of life according to 15D
questionnaire, To radiologically assess tumour density and morphology, and assess
alternative radiologic response evaluation in comparison with RECIST response criteria,
Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms
that may predict drug effects, safety, resectability and clinical behaviour of the
tumour
Feb 29,2012
All
18 Years
N/A
18 Years
N/A
100