* Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer. * Primary objective: Progression Free Survival (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 15-dimensional instrument (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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression
Department of Oncology
Helsinki, Finland
Resectability of metastases
To evaluate technical resectability rate of colorectal cancer metastasis after conversion therapy
Time frame: 5 years
Efficacy of alternating therapy
Progression free survival rate at 12 months
Time frame: 5 years
Response of alternating therapy
To assess response rates according to RECIST criteria
Time frame: 5 years
Efficacy of treatment
Overall survival
Time frame: 5 years
Progression-free survival
Progression-free survival
Time frame: 5 years
Translational research
Prognostic and predictive factors
Time frame: 10 years
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