Actively Recruiting

Age: 18Years +
FEMALE
ID06827353

Retrospective Study Comparing Niraparib Versus Bevacizumab as Maintenance Therapy After Platinum-based Chemotherapy in Patients With High-grade Stage III and IV Ovarian Cancer Without Homologous Recombination Deficiency

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

300

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief 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...

  • Female patients diagnosed with de novo stage III or IV high-grade epithelial ovarian carcinoma not eligible for primary tumor reduction surgery
  • Patients diagnosed with high-grade epithelial ovarian carcinoma treated with combination chemotherapy and maximal cytoreductive surgery
  • Patients who have received maintenance treatment with either bevacizumab or niraparib monotherapy after chemotherapy
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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Maintenance Therapy

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

Follow-up

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

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.

S

Sabrina Nicolas

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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Published Research Related To This Trial

Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.

A González-Martín, P Harter, A Leary...

https://pubmed.ncbi.nlm.nih.gov/37597580