Trial · NCT06827353
Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
NCT06827353, Recruiting, Centre Hospitalier Universitaire de Nīmes
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency. Trials, record NCT06827353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06827353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
- NCT number
- NCT06827353
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Conditions
- Ovarian Carcinoma
- Interventions
- maintenance therapy with bevacizumab, maintenance therapy with niraparib
- First posted
- 2025-02-14
- Last updated
- 2025-02-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival of patients with high-grade stage III and IV epithelial ovarian carcinoma who received chemotherapy between those who received maintenance treatment with bevacizumab and those who received niraparib. | From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months | Progression-free survival (PFS) defined as the time from initiation of maintenance therapy with bevacizumab monotherapy or niraparib to the date of disease progression or death from any cause. Disease progression is defined as cessation of maintenance therapy due to radiological and/or biological progression at the discretion of the oncologist managing the patient. |
| Secondary | Overall survival of the two groups | From date of maintenance therapy start until the date of death from any cause, assessed up to 38 months | Overall survival (OS) defined as time from initiation of maintenance therapy with bevacizumab monotherapy or niraparib to date of death from any cause |
| Other | CA-125 ELIMination rate constant K (KELIM) score between groups | From date of randomization until the date of death from any cause, whichever came first, assessed up to 38months | If CA-125 ELIMination rate constant K (KELIM) score result is less than value 1 patients will be classified as unfavorable risk. If KELIM score result equal or more than 1, patients will be classified as favorable risk. |
| Other | Radiological response | From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months | Radiologic response according on CT-scan after chemotherapy, at maintenance therapy will be adressed using the Response Evaluation Criteria In Solid Tumours version 1.1 as fur categories : progression disease, stable disease, partial response disease and complete response disease |
| Other | Comparrative performans status between two groups | From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months | Performance status Eastern Cooperative Oncology Group (PS ECOG) scalled from 0 to 5. Score 0 correspond to fully active, able to carry on all pre-disease performance without restriction. Score 5 correspond to Dead patient. |
| Other | Quality of surgical resection | From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months | This issue will be addressed using the pathologist and the residual tumor (R) classification. R0 corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06827353
GET https://conductscience.org/api/trials/v1/NCT06827353/registered