S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

Study Overview
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Brief Summary
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This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.

Official Title
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S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study

Conditions
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Esophageal Cancer, Chemoradiation

Intervention / Treatment
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* Radiation: Radiotherapy 54 Gy
* Radiation: Radiotherapy 60 Gy
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytologic diagnosis of esophageal carcinoma ECOG performance status 0-1 Age:70-85 years Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy Stage Ⅰ-ⅣB（AJCC 2009） Target lesions can be measured according to RECIST criteria No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN Exclusion Criteria: Multiple carcinomas of the esophagus, Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula, Metastatic disease (M1b), A primary tumor that extended to within 2 cm of the gastroesophageal junction, Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor, history of a second malignancy other than nonmelanoma skin cancer

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemoradiotherapy<br>Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42 | Radiation: Radiotherapy 54 Gy<br>* Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.<br>Drug: S-1<br>* S-1 70mg/m2 was administered on days 1-14 and 29-42.<br>|
| Active Comparator: Radiotherapy 60 Gy<br>Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly. | Radiation: Radiotherapy 60 Gy<br>* Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 2-year over survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 5 years | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 5 years |