Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the role of cytoreductive surgery and Niraparib maintenance in platinum-sensitive secondary recurrent ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Gynecologic Oncology Group
• Collaborators: Fudan University; Shanghai Jiao Tong University School of Medicine; Sun Yat-sen University; Zhejiang Cancer Hospital
• Treatments: Carboplatin; Doxorubicin; Gemcitabine; Niraparib; Taxane

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, which is defined as those with platinum-free interval of 6 months or more.

• Front-line or second-line treatment may have included maintenance therapy

• Never received secondary cytoreductive surgery when recurrence

• 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-look surgery, or palliative surgery planned.

• Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded.

• 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.