PARPi and Ovarian Cancer Survival

February 17, 2025 updated by: Shanghai Gynecologic Oncology Group

Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study

With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer or had platinum-sensitive first relapsed ovarian cancer between December 2013 and December 2024.

Description

Inclusion Criteria:

Group 1:

  • Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.
  • Complete data on first-line treatment and maintenance therapy.
  • Availability of follow-up data.

Group 2:

  • Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.
  • Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.
  • Complete data on second-line treatment and maintenance therapy.
  • Availability of follow-up data.

Exclusion Criteria:

Group 1:

  • Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
  • Missing first-line or follow-up data.

Group 2:

  • Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
  • Patients with second relapse.
  • Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.
  • Missing second-line or follow-up data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with newly diagnosed advanced epithelial ovarian cancer
Patients who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer between December 2013 and December 2024.
Patients with platinum-sensitive first relapsed epithelial ovarian cancer
Patients with platinum-sensitive first relapsed ovarian cancer who were diagnosed between December 2013 and December 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Mortality
Time Frame: 11 years
Mortality of any cause
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China
Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University
Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARPi_OC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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