The aim of this study is to investigate the efficacy and safety of enucleation of enlarged CPLNs in patients with advanced ovarian cancer.
This is an open-label, single-arm, single-centre clinical trial with a historical control design, designed to assess the difference in median recurrence-free survival (mRFS) between patients with stage III/IV cutaneous ovarian cancer, fallopian tube cancer or primary peritoneal cancer who undergo CPLNs resection and those who do not. The required sample size for the historical control group is 52 patients, and the required sample size for the CPLN resection group is also 52 patients. The study will assess the impact of CPLN resection on recurrence, whilst documenting perioperative safety, observing postoperative overall survival (OS) and changes in patients' postoperative quality of life, and finally analysing technical feasibility.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Diaphragmatic angle lymph node dissection
the first hospital of JILIN UNIVERSITY
Changchun, Jilin, China
RECRUITINGRFS
From the date of surgery until radiological confirmation of recurrence (RECIST 1.1) or death from any cause;
Time frame: experimental group 17.2 month
Recurrence-free survival (RFS)
From the date of surgery until radiological confirmation of recurrence (RECIST 1.1) or death from any cause;
Time frame: 9-17 month
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