Lung Cancer Clinical Trial
Official title:
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
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
- 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.
;
Allocation: Randomized, Primary Purpose: Prevention
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