This is a phase II/III randomized controlled trial to evaluate efficacy of platinum-based chemotherapy vs conventionally prescribed non-platinum monochemotherapy in patients with platinum-resistant ovarian cancer
Recurrent ovarian cancer (ROC) is usually subdivided to platinum-sensitive (platinum-free interval \[PFI\] ≥6 mo.) and platinum-resistant ovarian cancer \[PROC\] (PFI \<6 mo.) subtypes. Prognosis for the latter group is dismal and current guidelines recommend treating these patients with non-platinum based chemotherapy. However, the evidence behind this is quite unconvincing and according to recent data patients with non-platinum refractory platinum-resistant ovarian cancer could derive benefit from platinum rechallenge. This trial is designed for head-to-head comparison of platinum and non-platinum therapy efficacy in treatment of platinum-resistant ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Reintroduction of platinum-based chemotherapy
Conventional chemotherapy
N.N. Blokhin Cancer Research Center
Moscow, Russia
Objective response rate (RR) according to RECIST 1.1 criteria
Primary outcome for Phase II part: response rate to treatment according to RECIST1.1 criteria. For patients without measurable disease Rustin criteria is allowed.
Time frame: 0-18 weeks
Overall survival defined as time from randomization to death from any reason;
Primary outcome for Phase III part: 2. Overall survival defined as time from randomization to death from any reason
Time frame: 1 year
Progression-free survival
Progression-free survival (PFS) defined as time from randomization to disease progression according to RECIST 1.1 criteria or death from any reason;
Time frame: 12 months
Overall survival
Overall survival defined as time from randomization to death from any reason (for Phase II part only);
Time frame: 12 months
Progression-free survival 2 (PFS2)
PFS2 defined as time from randomization to second disease progression event according to RECIST 1.1 criteria or death from any reason;
Time frame: 24 months
Objective response rate (RR) according to RECIST 1.1 criteria
Response rate to treatment according to RECIST1.1 criteria. For patients without measurable disease Rustin criteria is allowed (only for Phase II part).
Time frame: 12 months
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