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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- 2-years Non-Progression Rate
Study Overview
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, 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Hepato-celiac lymphadenectomy
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).
Intervention: Hepato-celiac lymphadenectomy (Procedure)
Outcomes
Primary Outcomes
2-years Non-Progression Rate
Time Frame: 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 Outcomes
- Objective response rate(Participants will be followed up to 24 months after randomization)
- Overall survival(Participants will be followed up to 60 months after randomization)
- Patterns of subsequent recurrence(Participants will be followed up to 24 months after randomization)
- Quality of life assessments (QLQ-C30)(Baseline; 6 months, 12 months and 24 months after randomization)
- Progression free survival(Participants will be followed up to 24 months after randomization)
- Post-operative complications(Participants will be followed up to 90 days after randomization)
- Disease control rate(Participants will be followed up to 24 months after randomization)
- Quality of life assessments (FACT-Q)(Baseline; 6 months, 12 months and 24 months after randomization)