Lung Cancer Clinical Trial

ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Histologically confirmed non small cell lung cancer
Stage IV needing radiation therapy to control symptoms
Patients with brain metastases
Unresectable or medically inoperable

Exclusion Criteria:

Small cell lung cancer
Previous thoracic radiation therapy
Oxygen-dependent patients
Forced expiratory volume in 1 second (FEV1) less than 1.5
Patients with active interstitial lung disease
Patients with underlying lung disease

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT00328562

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT00328562

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Cancer Center at Thomas Jefferson University

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