Actively Recruiting

Age: 18Years +
FEMALE
NCT06827353

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-02-14

300

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of stage III or IV high-grade epithelial ovarian carcinoma without primary tumor reduction surgery
  • Diagnosis of high-grade epithelial ovarian carcinoma treated with chemotherapy and maximal cytoreductive surgery
  • Received maintenance treatment after chemotherapy with bevacizumab or niraparib alone
Not Eligible

You will not qualify if you...

  • Disease progression after chemotherapy
  • Presence of a BRCA mutation (somatic or germline)
  • Positive homologous recombination deficiency (HRD) score

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Nîmes

Nîmes, Occitanie, France, 30029

Actively Recruiting

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Research Team

S

Soufyan Annakib, M.D.

CONTACT

S

Sabrina Nicolas

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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