Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride. Secondary Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. 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. Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically. After completion of study therapy, patients are followed up periodically.

Official Title
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A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride
* Drug: gefitinib
* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Radiation: whole-brain radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Stage IIIB or IV disease Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy 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: Female Never smoked Histologically confirmed adenocarcinoma of the lung No evidence of brain metastases by CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 1,500/mm^3 Platelet count ≥ 150,000/mm^3 Bilirubin < 1.5 mg/dL Serum creatinine < 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: See Disease Characteristics Received 1 or 2 prior systemic chemotherapy regimens

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|
|Drug: gefitinib|nan|
|Other: questionnaire administration|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: whole-brain radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptomatic brain metastases |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Safety and tolerability of prophylactic cranial radiotherapy |  |  | 
| Psycho-neurological effects of prophylactic cranial radiotherapy |  |  | 
| Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer