Hepato-celiac lymphadenectomy for survival in primary or relapsed ovarian-related cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multi-center phase II surgical trial testing hepato-celiac lymphadenectomy in patients with hepato-celiac lymph node metastases from advanced primary or platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible patients must have imaging and intraoperative confirmation of hepato-celiac node involvement and be judged resectable by experienced surgeons; 1–3 cycles of neoadjuvant chemotherapy are allowed in the primary setting. The protocol focuses on safety and effectiveness outcomes related to complete resection and survival endpoints following hepato-celiac lymphadenectomy performed at participating centers. Patients will be followed postoperatively for complications and oncologic outcomes including progression-free and overall survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Libing Xiang
• Email: xiang.libing@zs-hospital.sh.cn
• Phone: 862164041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.