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
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.
Interventional
Allocation: Randomized, Primary Purpose: Prevention
Time to symptomatic brain metastases
No
Chang Geol Lee, MD
Principal Investigator
Yonsei University
Unspecified
CDR0000639096
NCT00955695
May 2009
Name | Location |
---|