This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2, 30min + Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.
Tongji Hospital
Wuhan, Hubei, China
Qilu Hospital, Shandong University, 107 West Wenhua Road
Ji'nan, Shandong, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Disease-free survival (DFS)
DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.
Time frame: 3 year
Overall survival (OS)
OS is defined as the time from the date of randomization until death of any cause.
Time frame: 3 year
5-year DFS/OS
DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first. OS is defined as the time from the date of randomization until death of any cause.
Time frame: 5 years
Incidence of Toxicity
The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0.
Time frame: 2 years
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