S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented diagnosis of esophageal Cancer Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible age:70-85 years Written informed consent. Performance status of 0 to 2 Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L. Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Exclusion Criteria: Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Prior systemic chemotherapy or radiation therapy for esophageal cancer

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemoradiotherapy with S-1<br>radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42 | Drug: S-1<br>* S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]). |  | dependent upon results | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S-1, radiation, esophageal Cancer