Non-Small Cell Lung Carcinoma (NSCLC) Clinical Trial
Official title:
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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