Clinical trial NCT06838429: PARPi and Ovarian Cancer Survival
Official title: Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
PARP Inhibitor
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Ovarian Cancer, Fudan University; Department of Gynecologic Oncology, Cancer Center, Fudan University Zhongshan Hospital, Shanghai, China
name: Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
name: Department of Gynecologic Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Sun Yat-sen University
name: Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China
First posted: 2025-02-20
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Mortality
timeFrame: 11 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: