S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
NCT02913066 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2017-06-16
Summary
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.
Conditions
Interventions
- OTHER
-
S-1 concurrent radiotherapy
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.
- OTHER
-
S-1 plus Cisplatin concurrent radiotherapy
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.
Sponsors & Collaborators
-
Mianyang Central Hospital
lead OTHER
Principal Investigators
-
Bo Du X, Doctor · Mianyang Central Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2019-03-31
- Completion
- 2019-03-31
Countries
- China
Study Locations
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