Phase 1
Completed N=13
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma (NSCLC)
Source: ClinicalTrials.gov NCT00328562 ↗
Enrolled (actual)
13
Serious AEs
41.7%
Results posted
Aug 2014
Primary outcomePrimary: Patients Affected by Treatment-related Morbidities — 12 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Affected by Treatment-related Morbidities |
12 | — |
| SECONDARY Tumor Response |
3; 1; 3; 1; 1; 3 | — |
| SECONDARY Progression-free Survival |
5 | — |
| SECONDARY Survival From Starting Gefitinib |
10 | — |
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
Data sourced from ClinicalTrials.gov (NCT00328562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.