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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

Criteria

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