This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Docetaxel: 20mg/m2/w for 6 weeks
a total dose of 60Gy in 30 fractions over 6 weeks
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Disease-free survival
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Time frame: 2 years
overall survival rate
from date of enrollment until date of first death from any cause, assessed up to 2 years
Time frame: 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
Time frame: up to 6-7 weeks
Late toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years
Time frame: up to 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
QoL score will be documented on each weekend during the course of radiotherapy
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
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