Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.

Trial Details

NCT ID
NCT03983226
Phase
PHASE2
Sponsor
Shanghai Gynecologic Oncology Group
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Surgery
  • carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
  • Niraparib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Guangzhou, China|23.11667,113.25
  • Hangzhou, China|30.29365,120.16142
  • Shanghai, China|31.22222,121.45806
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Age ≥18 years to ≤ 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Ovarian Cancer Trials on Trialify →