ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
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
Sponsor: AstraZeneca
Listed as NCT00328562, this PHASE1 trial focuses on Non-Small Cell Lung Carcinoma (NSCLC) and remains completed. Sponsored by AstraZeneca, it has been updated 10 times since 2003, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
10 versions recorded-
Mar 2026 — Present [monthly]
Completed PHASE1
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Feb 2026 — Present [monthly]
Completed PHASE1
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Jan 2026 — Present [monthly]
Completed PHASE1
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Jun 2025 — Feb 2026 [monthly]
Completed PHASE1
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Sep 2024 — Jun 2025 [monthly]
Completed PHASE1
▶ Show 5 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Dec 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AstraZeneca
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
For direct contact, visit the study record on ClinicalTrials.gov .