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

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

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.

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