S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT01175447|
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : March 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: S-1||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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
- 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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175447
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Study Chair:||Xianghui Du, MD||Zhejiang Cancer Hospital|