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)
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced
non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
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
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Shenglin Ma, MD
Zhejiang Cancer Hospital
China: Ethics Committee