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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PARPi + Bev | Experimental |
| |
| PARPi | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARP inhibitor + Bevacizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Time from randomization to any sign or symptom of the cancer or death from the disease | From enrollment through study completion, an average of 2 year |
| The frequency of adverse events | From date of first immunotherapy dose through 60 months, or date of last patient contact |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the first recurrence through study completion, an average of 2 year |
| Time from Randomization to First Subsequent Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Trukhan | Contact | 80291985715 | annavladimir@rambler.ru | |
| Sergey Mavrichev | Contact | smavrichev71@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Alexandrov National Caner Centre | Recruiting | Minsk | Lesnoy | 223040 | Belarus |
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|
| PARP inhibitor | Drug | 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. |
|
Time from randomization to the initiation of the next (second-line) therapy, most often due to disease progression. |
| 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 | Through study completion, an average of 5 year |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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