This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Disease-free survival (DFS)
Time frame: 2 years
Overall Survival (OS)
the time in months between the date of random assignment and the date of death from any cause
Time frame: 2 years
Locoregional failure-free survival (LRFS)
the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first
Time frame: 2 years
distant metastasis free survival (DMFS)
the time from random assignment to the first distant metastasis or death from any cause
Time frame: 2 years
Adverse Events (AE)
AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: 3 months
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