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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Gynecologic Oncology Group

About this 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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Patients with borderline tumors as well as non-epithelial tumors.

Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.

Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.

Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).

Trial design

Treatments tested in this trial

  • Surgery
  • carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
  • Niraparib

Treatment groups

167 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Gynecologic Oncology Group

Lead sponsor

Fudan University

Collaborator

Shanghai Jiao Tong University School of Medicine

Collaborator

Zhejiang Cancer Hospital

Collaborator

Sun Yat-sen University

Collaborator