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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2022 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 96 to 167v6 Show 5 more changesShow less
    • Primary completion date: Jun 2023 to Jun 2025
    • Study completion date: Dec 2024 to Dec 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints revised (5)
    • Study description shortened, about 7 words
  2. Enrollment target: 76 to 96v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 10 more changesShow less
    • Primary completion date: Sep 2022 to Jun 2023
    • Primary endpoint revised
    • Study sites: 1 to 5
    • Study completion date: Mar 2023 to Dec 2024
    • Start date changed from estimate of Jul 2019 to Oct 18, 2019
    • Interventions: Secondary cytoreductive surgery (Procedure), carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome… to Niraparib (Drug), Surgery (Procedure), carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome…
    • Eligibility criteria expanded, about 59 words
    • Study description expanded, about 7 words
    • Collaborators: 1 to 4
    • Study title expanded, about 2 words
  4. Secondary endpoints: 6 to 5v3
  5. Secondary endpoints: 5 to 6v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT03983226
Lead Sponsor Shanghai Gynecologic Oncology Group
Collaborators: Fudan University, Shanghai Jiao Tong University School of Medicine, Zhejiang Cancer Hospital, Sun Yat-sen University
Conditions
(from sponsor)		 Ovarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Related terms Fallopian Tube Neoplasms
Enrollment 167 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov