Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

Study Overview
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Brief Summary
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This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.

Official Title
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A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: SMART
* Drug: DDP
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically or cytologically confirmed esophageal squamous cell carcinoma. Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies. Aging from 70 to 80. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Charlson's weighted index of comorbidities (WIC) ≤4； White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. Weight loss ≤15% within the past half year. Forced expiratory volume in 1 s≥ 1 L. Patients and their family signed the informed consents. Exclusion Criteria: Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation. Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.) Malignant pleural effusion or pericardial effusion. Weight loss >10% within the past 3 months. Recruited in other clinical trials within 30 days Drug addiction, long-term alcohol abuse and AIDS patients. Uncontrollable epileptic attack 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: 70 Years
Maximum Age: 80 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: SMART & S-1/DDP<br>Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1. | Radiation: SMART<br>* Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )<br>Drug: DDP<br>* DDP(25 mg/m2.qw) for six weeks.<br>Drug: S-1<br>* S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate | the percentage of patients who had partial remission or complete remission after chemoradiotherapy | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 3-year | 
| overall survival |  | 3-year | 
| grade 3 or 4 toxicities according to CTCAE4.0 | the percentage of patients who develop grade 3 or 4 toxicities during and 1 year after radiochemotherapy | 1 year after radiochemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Once-daily Simultaneous Modulated Accelerated Radiotherapy, S-1, DDP, elderly patients