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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Erlotinib Hydrochloride; Gefitinib

Criteria

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