PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PARP inhibitor + Bevacizumab, PARP inhibitor.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.
Overview
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
- Drug PARP 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. - Drug PARP 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.
Primary outcome measures
- Disease-free survival [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]
Secondary outcome measures (3)
- Disease-free survival 2 [Time frame: From the first recurrence through study completion, an average of 2 year]
- Time from Randomization to First Subsequent Therapy [Time frame: From enrollment through study completion, an average of 2 year]
- The quality of life [Time frame: Through study completion, an average of 5 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belarus · 1 center
- N.N. Alexandrov National Caner Centre — Minsk
Identifiers
NCT: NCT07472140 · 20260012