A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study.
Tingyan Shi, Sheng Yin, Jianqing Zhu...
https://pubmed.ncbi.nlm.nih.gov/32319233Actively Recruiting
Phase 2
Age: 18Years - 75Years
FEMALE
ID03983226
A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
Led by Shanghai Gynecologic Oncology Group · Updated on 2022-03-18
167
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
Sponsors
S
Shanghai Gynecologic Oncology Group
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of cytoreductive surgery combined with Niraparib maintenance therapy compared to chemotherapy followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer. This Phase II, randomized, open-label trial is conducted across multiple centers and includes patients with different histories of PARP inhibitor use and secondary cytoreductive surgery at first recurrence. Participants are assigned to one of two groups: one receiving maximum effort cytoreductive surgery followed by platinum-based chemotherapy and Niraparib maintenance, and the other receiving platinum-based chemotherapy and Niraparib maintenance without surgery. The trial includes three cohorts based on prior treatments: those without prior PARP inhibitor use or secondary surgery, those with prior PARP inhibitor use but no secondary surgery, and those who had secondary surgery but no prior PARP inhibitor use. Throughout the study, participants will be monitored for disease progression up to 12 months after the last patient is randomized, with additional observations for progression-free survival, treatment-free survival, overall survival, post-operative complications, and quality of life assessments at baseline, 6 months, and 12 months. The study will involve imaging assessments and evaluations by experienced surgeons to determine the possibility of complete resection, with follow-up lasting up to 24 months after randomization.
CONDITIONS
Brief Title
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Who Can Participate
Age: 18Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Age �38 years to �3c= 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 such as bevacizumab or 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
- Complete resection of all recurrent disease is possible as assessed by experienced surgeons
- Single or localized lesions identified by CT, MRI, or PET/CT
- Single lesion outside the peritoneal cavity can be resected
- No more than 3 disease lesions if the center has not participated in surgical ovarian cancer trials before
- Patients must have signed informed consent
You will not qualify if you...
- Patients with borderline tumors or non-epithelial tumors
- Patients planned for interval-debulking, second- or third-look surgery, or palliative surgery
- Unable to assess resectability or signs suggesting complete resection is impossible
- Patients with more than two previous chemotherapy regimens (excluding maintenance)
- Patients with third relapse or more
- Patients with other malignancies treated by surgery that might interfere with ovarian cancer treatment or prognosis
- Progression during chemotherapy or recurrence within 6 months after second-line platinum therapy
- Any contraindications to surgery, chemotherapy, or Niraparib
- Severe chronic obstructive pulmonary disease with hypoxia
- Uncontrolled hypertension, stroke, heart attack, unstable angina, untreated thrombosis, congestive heart failure, or serious arrhythmia requiring medication
- Severe liver disease, nephrotic syndrome, or renal insufficiency
- Active ulcers, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Uncontrolled diabetes
- Uncontrolled epilepsy requiring long-term treatment
- Medications causing high risk for surgery, such as anticoagulants
- Grade 3 or higher anemia, neutropenia, or thrombocytopenia lasting more than 4 weeks
- Known allergy to Niraparib or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 30 days after surgery
Participants assigned to the surgery arm undergo maximum effort cytoreductive surgery for tumor removal, followed by post-operative care.
Approximately 1 surgery and several post-operative visits
Treatment
Duration - Duration of chemotherapy plus Niraparib maintenance period
Participants receive platinum-based chemotherapy followed by Niraparib maintenance therapy. Those in the non-surgery arm receive chemotherapy and Niraparib without surgery.
Visits according to chemotherapy and maintenance schedules
Follow-up
Duration - Up to 24 months after last patient randomized
Participants are monitored for disease progression, survival, and quality of life assessments after treatment completion.
Follow-up visits at baseline, 6 months, 12 months, and additional visits for survival monitoring
Trial Site Locations
Total: 5 locations
1
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, China
Not Yet Recruiting
4
Fudan University
Shanghai, China
Not Yet Recruiting
5
Shanghai Jiao Tong University
Shanghai, China
Not Yet Recruiting
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Research Team
R
Rong Jiang, M.D.
Y
Yuting Luan, R.N.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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