Clinical trial · Interventional
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
NCT00328562CI-TRIAL-00089291completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Carcinoma (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracic Radiotherapy | Radiation | — | UNRESOLVED |
| ZD1839 (Iressa) | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Iressa and RT
- description
- Iressa 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
- interventionNames
- Drug: ZD1839 (Iressa)
- Radiation: Thoracic Radiotherapy
Primary outcomes (1)
- measure
- Patients Affected by Treatment-related Morbidities
- timeFrame
- Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
- description
- See "Adverse Events" section for specific toxicities
Secondary outcomes (3)
- measure
- Tumor Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.