Comparing niraparib and bevacizumab for ovarian cancer maintenance therapy
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
This study is trying to see if a maintenance treatment with niraparib works better than bevacizumab for women with advanced ovarian cancer who have already had chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Nîmes, Occitanie) |
| Trial ID | NCT06827353 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the progression-free survival of patients with high-grade stage III and IV ovarian carcinoma who have received first-line platinum-based chemotherapy followed by maintenance treatment with either niraparib or bevacizumab. The study will utilize a retrospective, multicenter approach, analyzing data collected from patients' medical records. It focuses on patients without BRCA mutations or high homologous recombination deficiency scores, who are typically treated with these two maintenance therapies. The goal is to determine if there are significant differences in outcomes between the two treatment options.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with de novo high-grade serous epithelial ovarian carcinoma at stage III or IV who have received first-line chemotherapy.
Not a fit: Patients with a BRCA mutation or a positive HRD score will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which maintenance therapy offers better outcomes for patients with advanced ovarian cancer.
How similar studies have performed: While there have been studies on these treatments individually, this specific comparative approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Disease progression after chemotherapy * Presence of a BRCA mutation (somatic or germline) * Positive HRD score
Where this trial is running
Nîmes, Occitanie
- CHU de Nîmes — Nîmes, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: soufyan annakib, M.D.
- Study coordinator: Soufyan Annakib, M.D.
- Email: soufyan.annakib@gmail.com
- Phone: +33466683301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.