Incorporation of bevacizumab in the primary treatment of ovarian cancer.
Robert A Burger, Mark F Brady, Michael A Bookman...
https://pubmed.ncbi.nlm.nih.gov/22204724Actively Recruiting
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-02-14
300
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research aims to compare two maintenance treatments, bevacizumab and niraparib, in patients with advanced high-grade serous epithelial ovarian carcinoma (stage III and IV) who do not have certain biomolecular abnormalities like BRCA mutations or high HRD scores. The study focuses on progression-free survival and overall survival to help understand which treatment might be more appropriate for this patient group. It is a retrospective, observational study using medical records from patients treated between October 2020 and December 2023. Patients included in the study have received first-line platinum-based chemotherapy followed by maintenance therapy with either bevacizumab or niraparib. The study groups consist of patients who received niraparib monotherapy or bevacizumab monotherapy as maintenance treatment after chemotherapy. Data collection is retrospective, based on electronic case report forms from multiple centers. The study excludes patients with disease progression after chemotherapy or those with BRCA mutations or positive HRD scores. Participants' medical records are reviewed to collect clinical, biological, and sociodemographic data. The primary outcome is progression-free survival from the start of maintenance therapy until disease progression or death, assessed up to 38 months. Secondary outcomes include overall survival within the same timeframe. This study does not involve active treatment or visits but relies on existing data to analyze treatment outcomes and patient characteristics over time.
CONDITIONS
Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 38 months or until disease progression or death
Participants receive maintenance therapy with either bevacizumab or niraparib after completing platinum-based chemotherapy for advanced ovarian cancer.
Visits as per routine clinical care during maintenance therapy
Duration - Up to 38 months from start of maintenance therapy
Participants are monitored for progression-free and overall survival following maintenance therapy.
Visits as per routine clinical follow-up
Total: 1 location
1
CHU de Nîmes
Nîmes, Occitanie, France, 30029
Actively Recruiting
S
Soufyan Annakib, M.D.
S
Sabrina Nicolas
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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