🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05236686
Recruiting Not applicable

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

NCT05236686 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Gynecologic Oncology Group
Phase
Not applicable
Started
2022-02-15
Last updated
2025-11-19

Condition(s) studied

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Investigational drug(s) / intervention(s)

Hepato-celiac lymphadenectomy

Hepato-celiac lymphadenectomy: Hepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Study 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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai China Recruiting

More Shanghai Gynecologic Oncology Group trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05236686 on ClinicalTrials.gov ↗ ← All trials in China