A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase
II study when administered concurrently with thoracic radiation in elderly patients (>70
years old) with esophageal Cancer.
Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and
80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times
weekly to a total dose of 54 Gy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
3 months per patient
Xianghui Du, MD
Zhejiang Cancer Hospital
China: Food and Drug Administration