This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma. All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
Hui Liu
Guangzhou, Guangdong, China
Progression-Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
rate of grade 3-4 radiation esophagitis
Time frame: 1 year
rate of grade 3-4 radiation pneumonitis
Time frame: 1 year
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