Brief Title
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Official Title
A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
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.
Detailed Description
This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed
by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib
maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
12-month disease non-progression rate
Secondary Outcome
Progression-free survival
Condition
Ovarian Cancer Recurrent
Intervention
Surgery
Study Arms / Comparison Groups
Surgery
Description: Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
167
Start Date
October 18, 2019
Completion Date
December 2026
Primary Completion Date
June 2025
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.
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Tingyan Shi, M.D., Ph.D., +862164041990, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03983226
Organization ID
SGOG OV5
Secondary IDs
SGOG OV-05
Responsible Party
Sponsor
Study Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University
Study Sponsor
Tingyan Shi, M.D., Ph.D., Principal Investigator, Shanghai Gynecologic Oncology Group
Verification Date
March 2022