Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
Conditions
Brief summary
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.
Interventions
DRUGPARP inhibitor + Bevacizumab
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.
DRUGPARP inhibitor
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.
Sponsors
N.N. Alexandrov National Cancer Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18-≤75 years. * Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Possibility of performing diagnostic laparoscopy or cytoreductive surgery. * Presence of homologous recombination deficiency (HRD). * No contraindications to chemotherapy, or bevacizumab. * Signed informed consent to participate in the study.
Exclusion criteria
* Presence of another active malignant invasive neoplasm. * Pregnancy or lactation period. * Disease progression during treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | From enrollment through study completion, an average of 2 year | Time from randomization to any sign or symptom of the cancer or death from the disease |
| The frequency of adverse events | From date of first immunotherapy dose through 60 months, or date of last patient contact | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival 2 | From the first recurrence through study completion, an average of 2 year | 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 from Randomization to First Subsequent Therapy | From enrollment through study completion, an average of 2 year | Time from randomization to the initiation of the next (second-line) therapy, most often due to disease progression. |
| The quality of life | Through study completion, an average of 5 year | 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 |
Countries
Belarus
Contacts
CONTACTHanna Trukhan
CONTACTSergey Mavrichev
Outcome results
None listed