Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.

Detailed Description
-----------------
Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer. Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.

Official Title
-----------------
A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal

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

Intervention / Treatment
-----------------
* Drug: gefitinib
* Radiation: Thoracic radiotherapy


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant Gefitinib and radiotherapy<br>Patients received Gefitinib and radiation therapy | Drug: gefitinib<br>* gefitinib 250mg/day<br>Radiation: Thoracic radiotherapy<br>* Thoracic radiotherapy 54-60Gy over 30 fraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate |  | 1 month after the thoracic radiotherapy and concurrent gefitinib treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) |  | 1 month after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gefitinib, radiation, esophageal cancer