Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
- Conditions
- Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
- Interventions
- Procedure: Hepato-celiac lymphadenectomy
- Registration Number
- NCT05236686
- Lead Sponsor
- Shanghai Gynecologic Oncology Group
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 69
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hepato-celiac lymphadenectomy Hepato-celiac lymphadenectomy 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).
- Primary Outcome Measures
Name Time Method 2-years Non-Progression Rate Participants will be followed up to 2 years after randomization The proportion of patients without disease progression or death at 2 years after entry into the study.
- Secondary Outcome Measures
Name Time Method Progression free survival Participants will be followed up to 24 months after randomization The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Objective response rate Participants will be followed up to 24 months after randomization The proportion of patients who achieved complete response (CR) or partial response (PR)
Post-operative complications Participants will be followed up to 90 days after randomization Postoperative 30-day, 60-day and 90-day complications
Patterns of subsequent recurrence Participants will be followed up to 24 months after randomization The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.
Overall survival Participants will be followed up to 60 months after randomization The time from date of randomization until the date of death from any cause or last follow-up
Quality of life assessments (QLQ-C30) Baseline; 6 months, 12 months and 24 months after randomization 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).
Disease control rate Participants will be followed up to 24 months after randomization The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)
Quality of life assessments (FACT-Q) Baseline; 6 months, 12 months and 24 months after randomization 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).
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, China