PDS Versus NACT-IDS in AI-Selected Advanced Epithelial Ovarian Cancer

Ki vehet részt

• Female, aged ≥18 and <80 years
• Newly diagnosed, pathologically confirmed stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. Diagnostic surgery, core-needle biopsy, or a pleural/ascitic fluid cell block may be used for confirmation as specified in the protocol
• PET-CT based TNM clinical stage and cPCI tumor burden determined by multidisciplinary assessment
• Eastern Cooperative Oncology Group performance status 0-2
• Frailty index <0.15
• Known BRCA1/2 status
• MERITS recommendation for PDS and clinical eligibility for both randomized treatment strategies
• Adequate bone marrow, renal, hepatic, and nutritional function to undergo chemotherapy and surgery: white blood cell count >3,000/µL; absolute neutrophil count ≥1,500/µL; platelets ≥100,000/µL; hemoglobin ≥9 g/dL; serum creatinine <1.25 × upper limit of normal or creatinine clearance ≥60 mL/min; total bilirubin <1.25 × upper limit of normal; ALT and AST <2.5 × upper limit of normal; and serum albumin >3.5 g/dL
• Ability and willingness to comply with protocol treatment and scheduled follow-up
• Written informed consent

Ki nem vehet részt

• Prior neoadjuvant chemotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapy for the current disease
• Concurrent or uncontrolled malignancy diagnosed within the previous 5 years
• Non-epithelial ovarian malignancy or borderline ovarian tumor
• Severe systemic disease precluding surgery, including poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease, implanted cardiac pacemaker with clinically relevant comorbidity, moderately reduced cardiac ejection fraction, end-stage renal disease, myocardial infarction, cerebrovascular accident, uncontrolled infection, coagulation disorder, or another condition judged to make surgery or chemotherapy unsafe
• Low-grade ovarian carcinoma, mucinous ovarian carcinoma, or clear cell carcinoma
• Inability to complete the planned treatment course or follow-up
• Religious, psychological, or other circumstances that could interfere with informed consent, protocol adherence, or follow-up