Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
682
investigator-determined progression-free survival
Time frame: every 12 weeks until progression or up to 30 months (whichever occurs first)
biological progression-free survival by serum CA 125
Time frame: every 3 weeks until progression or up to 30 months (whichever occurs first)
Health related Quality of Life (QoL)
Time frame: Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first)
Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions
Time frame: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
Overall Survival
Time frame: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months
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