This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
Chemotherapy: Cisplatin and 5fluorouracil
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, China
Overall survival
Time frame: 2 years
Local-regional control
Time frame: 2 years
Distant metastasis-free survival
Time frame: 2 years
Disease-free survival
Time frame: 2 years after randomization
Acute and late toxicities using CTCAE v4.0
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.
Time frame: 2 years
Quality of life as assessed with FACT-E
FACT-E score
Time frame: 2 years
Quality of life as measured with EQ-5D
The score of EQ-5D questionnaire
Time frame: 2 years
Biomarkers
Time frame: 2 years
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