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Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer

RecruitingNAAges 18 Years - 75 YearsFemaleShanghai Gynecologic Oncology Group
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma. * Low-grade carcinoma. * Mucinous ovarian cancer. * Infeasible complete resection according to preoperative evaluation * Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation. * Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy. * Progression after neoadjuvant chemotherapy in primary settings. * Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (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.
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What it tests

  • Hepato-celiac lymphadenectomy
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Where

1 site
Zhongshan Hospital, Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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