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

Study Overview
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Brief Summary
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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.

Detailed Description
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This single-arm, single-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).

Official Title
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A Prospective, Single-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

Conditions
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Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Procedure: Hepato-celiac lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepato-celiac lymphadenectomy<br>This single-arm, single-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). | Procedure: Hepato-celiac lymphadenectomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-years Non-Progression Rate | The proportion of patients without disease progression or death at 2 years after entry into the study. | Participants will be followed up to 2 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first | Participants will be followed up to 24 months after randomization | 
| Overall survival | The time from date of randomization until the date of death from any cause or last follow-up | Participants will be followed up to 60 months after randomization | 
| Objective response rate | The proportion of patients who achieved complete response (CR) or partial response (PR) | Participants will be followed up to 24 months after randomization | 
| Disease control rate | The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD) | Participants will be followed up to 24 months after randomization | 
| Post-operative complications | Postoperative 30-day, 60-day and 90-day complications | Participants will be followed up to 90 days after randomization | 
| Quality of life assessments (QLQ-C30) | Assessment of potential impact of first line treatment on functionality and well-being in patients by the EORTC core quality of life questionnaire (QLQ-C30, version 3.0). | Baseline; 6 months, 12 months and 24 months after randomization | 
| Quality of life assessments (FACT-Q) | Assessment of potential impact of first line treatment on functionality and well-being in patients by functional assessment of cancer therapy-ovary (FACT-O, version 4). | Baseline; 6 months, 12 months and 24 months after randomization | 
| Patterns of subsequent recurrence | The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc. | Participants will be followed up to 24 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Surgery, Lymph Node Metastasis, Hepato-celiac Lymphadenectomy