Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
Recruiting now
Conditions studied: Ovarian Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06827353
- Run by
- Centre Hospitalier Universitaire de Nīmes
- People needed
- 300
- Starts
- 2020-10-01
- Expected to finish
- 2025-09-30
- Last updated by the study team
- 2025-02-14
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- De novo diagnosis of stage III or IV high-grade epithelial ovarian carcinoma, not candidate for primary tumor reduction surgery.
- De novo diagnosis of high-grade epithelial ovarian carcinoma benefiting from a combination of chemotherapy and maximal cytoreduction surgery
- All patients who have received maintenance treatment after chemotherapy with bevacizumab or niraparib monotherapy.
You may not qualify if…
- Disease progression after chemotherapy
- Presence of a BRCA mutation (somatic or germline)
- Positive HRD score
Where it is running
- CHU de Nîmes — Nîmes, Occitanie, France (enrolling)
Full record on ClinicalTrials.gov
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