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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
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).
Zhongshan Hospital, Fudan University
Shanghai, China
RECRUITING2-years Non-Progression Rate
The proportion of patients without disease progression or death at 2 years after entry into the study.
Time frame: Participants will be followed up to 2 years after randomization
Progression free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Participants will be followed up to 24 months after randomization
Post-operative complications
Postoperative 30-day, 60-day and 90-day complications
Time frame: 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).
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Time frame: 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).
Time frame: 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.
Time frame: Participants will be followed up to 24 months after randomization