NCT03983226 Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
| NCT ID | NCT03983226 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Gynecologic Oncology Group |
| Condition | Ovarian Cancer Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 167 participants |
| Start Date | 2019-10-18 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 167 participants in total. It began in 2019-10-18 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) * Cohort 1 and Cohort 3: No prior use of PARP inhibitor. * Cohort 2: Prior use of PARP inhibitor. * Cohort 3: No prior use of PARP inhibitor. * Secondary cytoreductive surgery (SCR) when first recurrence * Cohort 1 and Cohort 2: Never received SCR * Cohort 2: Never received SCR * Cohort 3: Received SCR * Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis. * It can be included if single lesion outside the peritoneal cavity can be resected. * No more than 3 disease lesions by central-reviewed PET/CT imaging if the participated center has never participated in any surgical trials on ovarian cancer before. * Patients who have given their signed and written informed consent and their consent. Exclusion Criteria: * 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). * Third relapse or more. * Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. * Progression during chemotherapy or recurrence within 6 months after second-line platinum-based therapy * Any contradiction not allowing surgery and/or chemotherapy and/or or Niraparib * Accompanied by hypoxia serious chronic obstructive pulmonary disease * Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine. * Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency * Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy. * Uncontrolled diabetes * Uncontrolled epilepsy need long-term antiepileptic treatment. * Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents. * ≥3 grade anemia, neutropenia or thrombocytopenia due to chemotherapy, and lasted for more than 4 weeks * Patients with a known hypersensitivity to Niraparib or any of the excipients of the product.
Contact & Investigator
Tingyan Shi, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Shanghai Gynecologic Oncology Group
Frequently Asked Questions
Who can join the NCT03983226 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Ovarian Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03983226 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03983226 currently recruiting?
Yes, NCT03983226 is actively recruiting participants. Contact the research team at jiang.rong@zs-hospital.sh.cn for enrollment information.
Where is the NCT03983226 trial being conducted?
This trial is being conducted at Shanghai, China, Guangzhou, China, Hangzhou, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT03983226 clinical trial?
NCT03983226 is sponsored by Shanghai Gynecologic Oncology Group. The principal investigator is Tingyan Shi, M.D., Ph.D. at Shanghai Gynecologic Oncology Group. The trial plans to enroll 167 participants.
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