Clinical trial · Interventional
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
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
NCT05236686CI-TRIAL-00097538recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepato-celiac lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hepato-celiac lymphadenectomy
- description
- This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, 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).
- interventionNames
- Procedure: Hepato-celiac lymphadenectomy
Primary outcomes (1)
- measure
- 2-years Non-Progression Rate
- timeFrame
- Participants will be followed up to 2 years after randomization
- description
- The proportion of patients without disease progression or death at 2 years after entry into the study.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.