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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
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Age 18-70 years;
Histologically confirmed epithelial ovarian cancer (excluding mucinous, clear-cell and low-grade subtypes);
Ovarian cancer recurrence within 3-6 months after completion of platinum-based chemotherapy (given to possible variability in follow-up practices and tumor growth kinetics patients with platinum-free interval ≥3 and <7 months will be considered platinum-resistant);
Platinum-free interval ≤12 months;
Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
Response to penultimate platinum-based chemotherapy defined as partial or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or ≥50% reduction in CA-125 concentration for patients without measurable lesions;
Not refractory to penultimate platinum-based chemotherapy regimen (ie, the disease did not progress during platinum-based chemotherapy and within ≤3 months after its completion);
Patients received ≤3 lines of prior chemotherapy;
No central nervous system (CNS) metastatic involvement;
No severe and uncontrolled concomitant diseases;
Adequate organ function:
Known BRCA1/2 mutation status as it will be used for stratification;
Life expectancy >3 months;
Patient is willingly consent to participate in the trial and signed informed consent form
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
164 participants in 2 patient groups
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Central trial contact
Alexey Rumyantsev, MD
Data sourced from clinicaltrials.gov
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