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
3 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 19, 2006
CompletedFirst Posted
Study publicly available on registry
May 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
August 11, 2014
CompletedMay 4, 2025
May 1, 2025
4.3 years
May 19, 2006
June 9, 2014
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients Affected by Treatment-related Morbidities
See "Adverse Events" section for specific toxicities
Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
Secondary Outcomes (3)
Tumor Response
Baseline, 1, 3, and 5 months post-treatment
Progression-free Survival
Baseline to date of progression
Survival From Starting Gefitinib
Baseline to date of expiration
Study Arms (1)
Iressa and RT
EXPERIMENTALIressa 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
Eligibility Criteria
You may qualify if:
- Histologically confirmed non small cell lung cancer
- Stage IV needing radiation therapy to control symptoms
- Patients with brain metastases
- Unresectable or medically inoperable
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maria Werner-Wasik, MD
- Organization
- Thomas Jefferson University
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Werner-Wasik, MD
Thomas Jefferson University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2006
First Posted
May 22, 2006
Study Start
December 1, 2003
Primary Completion
April 1, 2008
Study Completion
September 1, 2010
Last Updated
May 4, 2025
Results First Posted
August 11, 2014
Record last verified: 2025-05