Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

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

Details

• Lead Sponsor: Shanghai Gynecologic Oncology Group
• Collaborator: Fudan University
• Treatments: Niraparib; Poly(ADP-ribose) Polymerase Inhibitors

Criteria

Inclusion Criteria:

• Females aged ≥ 18 years.

• Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma

• Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative PET/CT examination

• Complete cytoreduction can be achieved based on PET/CT examination

• Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing

• Performance status (ECOG 0-2)

• Good ASA score (1/2)

• Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:

1. white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,

2. serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,

3. serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.

• Comply with the study protocol and follow-up.

• Patients who have given their written informed consent.

Exclusion Criteria:

• Non-epithelial ovarian malignancies and borderline tumors

• Low grade ovarian cancer

• Mucinous ovarian cancer

• Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases

• Patient has a known hypersensitivity to the components of niraparib or its excipients

• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).

• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.

• Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.