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

NCT03983226 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2022-03-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Surgery

Tumor debulking surgery (surgery in recurrent ovarian disease)

DRUG

carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...

Salvage chemotherapy

DRUG

Niraparib

Niraparib maintenance therapy

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Shanghai Gynecologic Oncology Group

    lead OTHER_GOV

Principal Investigators

  • Tingyan Shi, M.D., Ph.D. · Shanghai Gynecologic Oncology Group

  • Rongyu Zang, M.D., Ph.D. · Shanghai Gynecologic Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983226 on ClinicalTrials.gov