Hepato-celiac lymphadenectomy for survival in primary or relapsed ovarian-related cancers
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
This trial will try hepato-celiac lymphadenectomy to see if removing hepato-celiac lymph nodes helps adults with advanced or platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal cancer that has spread to those nodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shanghai Gynecologic Oncology Group Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05236686 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with pathologically confirmed stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, or platinum-sensitive relapse (≤4 prior therapy lines) who have imaging- and surgically-confirmed hepato-celiac node metastases, ASA 1–2, ECOG 0–2, adequate organ function, and are judged resectable.
Not a fit: Patients without hepato-celiac node involvement, those with platinum-resistant disease, unresectable disease, poor performance status, or significant comorbidities are unlikely to benefit from this surgical approach.
Why it matters
Potential benefit: If successful, removing hepato-celiac lymph nodes could improve local disease control and potentially extend progression-free and overall survival for patients with node-positive disease.
How similar studies have performed: While lymphadenectomy in ovarian cancer has produced mixed results and remains controversial, hepato-celiac lymphadenectomy specifically is relatively untested in prospective trials with only limited retrospective reports suggesting possible benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Libing Xiang
- Email: xiang.libing@zs-hospital.sh.cn
- Phone: 862164041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.