Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer. The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
Concurrent radiotherapy: 50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGoverall survival, OS
Time frame: 2 years
progression-free survival
Time frame: 2 years
overall remission rate, ORR
Time frame: 16 weeks
serious adverse event
Time frame: 16 weeks
quality of life, Qol
Time frame: 16 weeks
pathologic complete response rate
Time frame: 16 weeks
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