Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Therefore this study investigates the combination of capecitabine and bevacizumab versus the combination of capecitabine, bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is time-of-failure strategy (TFS) comparing both treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
516
Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
Bevacizumab: 7.5 mg/kg day 1 q day 21
Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
University of Munich - Klinikum der Universitaet Muenchen
Munich, Germany
RECRUITINGTFS
Time of Failure Strategy
Time frame: 9 months
ORR, OS, Quality of Life, PFS-1
Time frame: 36 months
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Irinotecan: 200 mg/m2 day 1 , q day 21
Bevacizumab: 7.5 mg/kg day 1, q day 21