PARPi and Ovarian Cancer Survival

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.

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Key information

Conditions

Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms PARP Inhibitor Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Overall Mortality

Time frame: 11 years

Mortality of any cause

Sponsors and collaborators

Lead sponsor

Shanghai Gynecologic Oncology Group

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 20, 2025
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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