Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
2 other identifiers
interventional
167
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2019
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 18, 2022
March 1, 2022
5.6 years
June 5, 2019
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month disease non-progression rate
12-month non-progression rate
up to 12 months after last patient randomized
Secondary Outcomes (5)
Progression-free survival
Up to 24 months after last patient randomized
Treatment free survival
Up to 24 months after last patient randomized
Overall survival
Approximately up to 24 months after last patient randomized
30-day post-operative complications
From the operation until after 30 days
Quality of life assessment
baseline; 6 and 12 months after randomization
Study Arms (2)
Surgery
EXPERIMENTALIntervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
No surgery
ACTIVE COMPARATORIntervention: Drug: Platinum-based chemotherapy and Niraparib
Interventions
Tumor debulking surgery (surgery in recurrent ovarian disease)
Salvage chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Gynecologic Oncology Grouplead
- Fudan Universitycollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
- Zhejiang Cancer Hospitalcollaborator
- Sun Yat-sen Universitycollaborator
Study Sites (5)
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Fudan University
Shanghai, China
Shanghai Jiao Tong University
Shanghai, China
Related Publications (1)
Shi T, Yin S, Zhu J, Zhang P, Liu J, Zhu Y, Wu S, Chen X, Wang X, Teng Y, Zhu T, Yu A, Zhang Y, Feng Y, Huang H, Bao W, Li Y, Jiang W, Zhang P, Li J, Ai Z, Zhang W, Jia H, Zhang Y, Jiang R, Zhang J, Gao W, Luan Y, Zang R. A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study. J Gynecol Oncol. 2020 May;31(3):e61. doi: 10.3802/jgo.2020.31.e61.
PMID: 32319233DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tingyan Shi, M.D., Ph.D.
Shanghai Gynecologic Oncology Group
- STUDY CHAIR
Rongyu Zang, M.D., Ph.D.
Shanghai Gynecologic Oncology Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 12, 2019
Study Start
October 18, 2019
Primary Completion
June 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
March 18, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share