Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328562
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2006-05-19
Brief Title:
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003-07 | OTHER | CCRRC | None |