A Prospective, Multi-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer
The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.
• Age ≥18 years to ≤ 75 years.
• Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
• Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings
• Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
• 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
• Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
• ASA score of 1 to 2
• ECOG performance status of 0 to 2
• Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
• White blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
• Serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL
• Comply with the study protocol and follow-up.
• Written informed consent.