RecruitingNCT06827353

Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency

Retrospective Study to Evaluate Niraparib Versus Bevacizumab as Maintenance Therapy After First-line Treatment With Platinum-based Chemotherapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

300 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Background: High-grade serous epithelial ovarian cancer is a disease with a poor prognosis in the advanced stages (stages III and IV). For patients with no biomolecular abnormalities, there are two maintenance treatments available after first-line chemotherapy: bevacizumab or niraparib. There is no prospective or strong retrospective study comparing these two therapies. Hypothesis: Patients receiving bevacizumab are different from those receiving niraparib. Objective: To compare the progression-free survival (PFS) of patients with high-grade stage III and IV ovarian carcinoma who received chemotherapy with those who received maintenance treatment with bevacizumab and those who received niraparib. Method: Retrospective, multicenter study based on data collected from the patient's medical record. Eligible patients are all patients diagnosed with de novo high-grade serous epithelial ovarian carcinoma who have received first-line platinum-based chemotherapy followed by maintenance treatment with bevacizumab or niraparib. All eligible patients will be included. Patients with a BRCA mutation and/or a positive HRD score will be excluded. Data will be collected using an electronic CRF. The inclusion period is from October 2020 to December 2023.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two maintenance therapies — niraparib (a targeted pill) versus bevacizumab (an IV infusion) — for people newly diagnosed with advanced ovarian cancer who do not have a specific genetic vulnerability called HRD (homologous recombination deficiency). Maintenance therapy is given after initial chemotherapy to try to keep the cancer from coming back. **You may be eligible if...** - You have been newly diagnosed with Stage III or IV high-grade epithelial ovarian cancer - You were not able to have primary surgery to remove the tumor, or you had surgery combined with chemotherapy - You have already received maintenance treatment with either bevacizumab or niraparib after chemotherapy **You may NOT be eligible if...** - Your cancer progressed (got worse) during chemotherapy - You carry a BRCA gene mutation (either inherited or tumor-based) - Your tumor tested positive for HRD (a marker of genetic repair problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmaintenance therapy with bevacizumab

Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received bevacizumab after chemotherapy.

DRUGmaintenance therapy with niraparib

Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received niraparib after chemotherapy.


Locations(1)

CHU de Nîmes

Nîmes, Occitanie, France

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NCT06827353


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