Status:
UNKNOWN
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ef...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00955695
Start Date
May 1 2009
Last Update
August 2 2013
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