S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer|
- Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer [ Time Frame: 3 months per patient ] [ Designated as safety issue: Yes ]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.
- Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]). [ Time Frame: dependent upon results ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Chemoradiotherapy with S-1
radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42
S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175447
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Study Chair:||Xianghui Du, MD||Zhejiang Cancer Hospital|