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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000639096 | Registry Identifier | PDQ (Physician Data Query) |
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RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
After completion of study therapy, patients are followed up periodically.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | |||
| gefitinib | Drug | |||
| questionnaire administration | Other | |||
| quality-of-life assessment | Procedure | |||
| whole-brain radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to symptomatic brain metastases |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | ||
| Overall survival | ||
| Safety and tolerability of prophylactic cranial radiotherapy |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
Stable disease allowed provided 1 of the following criteria is met:
EGFR mutation (exon 19 or 21)
Having ≥ 2 of the following 3 factors:
No evidence of brain metastases by CT scan or MRI within the past 4 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Geol Lee, MD | Yonsei University | Principal Investigator |
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| Psycho-neurological effects of prophylactic cranial radiotherapy |
| Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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