Non-small Cell 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 Effective on Erlotinib or Gefitinib(RT1001)
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 with good response( CR/PR) to
EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI
alone,stratified according to prior chemotherapy regimens (first line vs second line), and
disease response status.
Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo
observation. Patients complete quality of life questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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