Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy; control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 \~ 42 days, plus cisplatin first 1\~ 4 days and 29 \~ 33 days. Using IMRT radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, or S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle. Primary Outcome Measure is complete remission rate. Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~33 planning target volume times, 60\~66 Gray/28\~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1\~ 14 days, 21 days for a cycle.
Radiotherapy 60\~66 Gray/28\~33 times (50.4\~60 Gray /28\~30 planning target volume times, Gross tumor volume of primary tumor60\~66 Gray/28\~33), synchronous chemotherapy S-1 70 mg/m2 1\~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1\~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1\~ 14 days, plus cisplatin 25mg/m2 1\~ 4 days, 21 days for a cycle.
Xiaobo du
Mianyang, Sichaung, China
RECRUITINGComplete Remission Rate (CR)
Complete response rate of primary tumor which will be measured by endoscopy and computer tomography
Time frame: Three months after radiotherapy finished
Overall Survival (OS)
The time from treatment completion to patient death
Time frame: Two years after adjuvant chemotherapy finished
Progression-Free-Survival (PFS)
The time from treatment completion to disease progression
Time frame: Two years after adjuvant chemotherapy finished
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