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

Summary

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.

Eligibility

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.

Conditions4

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