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Recruiting Phase 2 NCT05200260

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

Trial Parameters

Condition Ovarian Cancer
Sponsor Shanghai Gynecologic Oncology Group
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 220
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-07-13
Completion 2027-06
Interventions
Primary debulking surgeryNeoadjuvant chemotherapyPARP inhibitor

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Females aged ≥ 18 years. * Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma * Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination * Complete cytoreduction can be achieved based on CT or PET/CT examination * Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing * Performance status (ECOG 0-2) * 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. * Patient

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