This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel + bevacizumab (≥3 cycles) every 21 days. In case of a complete or partial response maintenance therapy is carried out until disease progression or intolerable toxicity or for 2 years to the regimen of PARP inhibitor + bevacizumab.
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel every 21 days. In case of a complete or partial response maintenance therapy of PARP inhibitor is carried out until disease progression or intolerable toxicity or for 2 years.
N.N. Alexandrov National Caner Centre
Minsk, Lesnoy, Belarus
RECRUITINGDisease-free survival
Time from randomization to any sign or symptom of the cancer or death from the disease
Time frame: From enrollment through study completion, an average of 2 year
The frequency of adverse events
Time frame: From date of first immunotherapy dose through 60 months, or date of last patient contact
Disease-free survival 2
Time from the first recurrence when patient remains free of cancer signs or symptoms to any sign or symptom of the cancer or death from the disease
Time frame: From the first recurrence through study completion, an average of 2 year
Time from Randomization to First Subsequent Therapy
Time from randomization to the initiation of the next (second-line) therapy, most often due to disease progression.
Time frame: From enrollment through study completion, an average of 2 year
The quality of life
Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scales range from 0 to 100; higher scores indicate better outcomes on functional and global health scales, but worse outcomes on symptom scales
Time frame: Through study completion, an average of 5 year
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