This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
820
As prescribed
Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
Unnamed facility
Dornbirn, Austria
Unnamed facility
Fürstenfeld, Austria
Unnamed facility
Graz, Austria
Unnamed facility
Graz, Austria
Unnamed facility
Hall in Tirol, Austria
Unnamed facility
Innsbruck, Austria
Overall Survival: Time From Randomization to Death From Any Cause
Time frame: within 6.5 years
Overall Survival: Months From Time of First Line Therapy
Time frame: within approximately 9.6 years
Participants With Progression Free Survival Event
Time frame: within 6.5 years
Progression Free Survival: Time to Event
Time frame: within 6.5 years
Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria
Time frame: within 6.5 years
Response Rate: Participants With Response Status Based on RECIST Criteria
Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Time frame: within 6.5 years
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Unnamed facility
Krems, Austria
Unnamed facility
Leoben, Austria
Unnamed facility
Linz, Austria
Unnamed facility
Rankweil, Austria
...and 290 more locations