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

Sponsor
Shanghai Gynecologic Oncology Group
Study ID
NCT03983226
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fallopian Tube Cancer
  • Ovarian Cancer Recurrent
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Tumor debulking surgery (surgery in recurrent ovarian disease)
  • carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... — DRUG
    Salvage chemotherapy
  • Niraparib — DRUG
    Niraparib maintenance therapy

Study Details

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.

Key Dates

Start date
Oct 18, 2019
Status verified
Mar 2022
Primary completion
Jun 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
167 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surgery
    Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
  • Active Comparator: No surgery
    Intervention: Drug: Platinum-based chemotherapy and Niraparib

Primary Outcome Measure

12-month disease non-progression rate [ Time Frame: up to 12 months after last patient randomized ]

Central Contacts

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