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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Surgery
Procedure/SurgeryTumor debulking surgery (surgery in recurrent ovarian disease)
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
DrugSalvage chemotherapy
Niraparib
DrugNiraparib maintenance therapy
Treatment groups
167 Participants
are divided into 2 treatment groupsGroup A: SurgeryExperimental treatment 3 interventions
Group B: No surgeryActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
12-month disease non-progression rate
12-month non-progression rate
Time frame
up to 12 months after last patient randomizedSecondary outcomes
1
Progression-free survival
from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)
Time frame
Up to 24 months after last patient randomized2
Treatment free survival
It is the area between Kaplan-Meier curves for two time-to-event end points: 1) time to protocol chemotherapy cessation and 2) time to first subsequent anticancer therapy initiation or death, whichever occurred first.
Time frame
Up to 24 months after last patient randomized3
Overall survival
from date of randomization until the date of death from any cause
Time frame
Approximately up to 24 months after last patient randomized4
30-day post-operative complications
surgical complications grading criteria will be adopted for evaluating the perioperative complications
Time frame
From the operation until after 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov