This prospective randomized controlled clinical Trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. The objectives of the trial are to compare the efficacy and safety of Capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
1000-1250 mg/m2 orally twice daily for 14 days followed by a 1-week rest period, given as 3- week cycles for a total of 6 cycles .
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPFS (progression free survival)
PFS is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Time frame: 3-year
Overall survival
Overall survival is calculated from the date of randomization to death from any cause.
Time frame: 3-year
Locoregional failure-free survival
Locoregional failure-free survival is calculated from the date of randomization to the first locoregional failure.
Time frame: 3-year
Distant failure-free survival
Distant failure-free survival is calculated from the date of randomization to the first remote failure.
Time frame: 3-year
QoL(quality of life)
Changes in quality of life were assessed by EORTC C30; QLQ-H\&N35 (V1.0)
Time frame: 3-year
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