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A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response. To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Start Date
December 1, 2003
Primary Completion Date
April 1, 2008
Completion Date
September 1, 2010
Last Updated
May 4, 2025
13
ACTUAL participants
ZD1839 (Iressa)
DRUG
Thoracic Radiotherapy
RADIATION
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators
Data Source & Attribution
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