Conditions: Non-Small Cell Lung Carcinoma (NSCLC)
Keywords: Advanced NSCLC Non-Small Cell Lung Carcinoma Stage IV NSCLC
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Iressa plus thoracic RT at the following dose levels:

* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy

Interventions: intervention 1: ZD1839 (Iressa) intervention 2: Thoracic Radiotherapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: