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RECRUITING
NCT06827353

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

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2020-10-01

Completion Date

2025-09-30

Last Updated

2025-02-14

Healthy Volunteers

No

Interventions

DRUG

maintenance 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.

DRUG

maintenance 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