This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Local control rate
The outcome measure will be assessed by every 3-month follow-up examinations.
Time frame: the date of randomization until progression inside the irradiation field, up to 3 years.
overall survival
The survival time from date of randomization to the day of death or the last follow-up.
Time frame: the date of randomization until the death or the last follow up of the patients, up to 3 years.
progress-free survival
Measured from date of randomization until progression or death from any cause
Time frame: the date of randomization until progression or death from any cause, up to 3 years
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