Actively Recruiting
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Led by Shanghai Gynecologic Oncology Group · Updated on 2022-03-18
167
Participants Needed
5
Research Sites
371 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
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.
CONDITIONS
Official Title
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- 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 must be 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 included if resectable
- No more than 3 disease lesions by central-reviewed PET/CT imaging if center has not participated in surgical ovarian cancer trials
- Signed and written informed consent obtained
You will not qualify if you...
- Borderline tumors or non-epithelial tumors
- Planned interval-debulking, second- or third-look surgery, or palliative surgery
- Impossible to assess resectability or radiological signs suggesting complete resection is impossible
- More than two previous chemotherapy regimens (excluding maintenance therapy)
- Third relapse or more
- Other malignancies treated by surgery that may interfere with treatment or prognosis
- Progression during chemotherapy or recurrence within 6 months after second-line platinum therapy
- Contraindications to surgery, chemotherapy, or Niraparib
- Serious chronic obstructive pulmonary disease with hypoxia
- Uncontrolled hypertension, stroke, heart attack, unstable angina, untreated thrombosis, heart failure, or serious arrhythmia
- Severe liver disease, nephrotic syndrome, or kidney failure
- Active ulcers, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Uncontrolled diabetes
- Uncontrolled epilepsy requiring long-term treatment
- Medication causing significant surgical bleeding risk
- Grade 3 or higher anemia, neutropenia, or thrombocytopenia lasting more than 4 weeks
- Known allergy to Niraparib or its ingredients
AI-Screening
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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
Research Team
R
Rong Jiang, M.D.
CONTACT
Y
Yuting Luan, R.N.
CONTACT
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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