Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

Detailed Description
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This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma. All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Official Title
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A Prospective, Phase Ⅱ Study of S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Combination Product: Moderately hypofractionated conformal radiation combined With S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed esophageal squamous cell carcinoma Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography. Eastern Cooperative Oncology Group (ECOG) performance status 1-2 Estimated life expectancy of at least 12 weeks Charlson comorbidity index.4 Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1 Adequate renal function: creatinine grade 0 or 1 Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit Weight loss.15% during 6 months prior to diagnosis Forced expiratory volume second.1L Exclusion Criteria: Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy Contraindication for chemotherapy or radiotherapy Malignant pleural or pericardial effusion Women in pregnancy or lactation period Women who has the probability of pregnancy without contraception Weight loss≥15% during 3 months prior to diagnosis In other clinical trials within 30 days Addicted in drugs or alcohol, AIDS patients Uncontrollable seizure or psychotic patients without self-control ability Severe allergy or idiosyncrasy Not suitable for this study judged by researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment<br>All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. | Combination Product: Moderately hypofractionated conformal radiation combined With S-1<br>* All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 
| rate of grade 3-4 radiation esophagitis |  | 1 year | 
| rate of grade 3-4 radiation pneumonitis |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Squamous Cell Carcinoma, Hypofractionated Conformal Radiation, S-1