This is a randomized, prospective, multicenter study.
This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.
Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week. Radiotherapy dose:95% gross tumor volume(GTV-T) 60-66 Gy /30-33f,GTV-N 60-66 Gy /30-33f,CTV-T 50-54 Gy /25-27f,CTV-N 50-54 Gy /25-27f.
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
Body Weight Change from baseline to the end of treatment
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
Time frame: up to 1 month after the treatment
Maximum Body Weight Change during treatment
Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.
Time frame: up to 1 month after the treatment
Blood biochemical examination
albumin, haemoglobin,et al
Time frame: up to 1 month after the treatment
Grade 3-5 toxicity
Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ,such as esophagitis、pneumonitis 、hematologic toxicity and infection rate
Time frame: up to 1 month after the treatment
Completion rate of chemoradiotherapy
The proportion of people who complete all treatment as required
Time frame: up to 1 month after the treatment
short-term effect
objective remission rate
Time frame: up to 1 month after the treatment
Overall Survival
overall survival
Time frame: at least 2 years
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