A Randomised Phase II Double Blind Placebo Controlled Trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Multiple Brain Metastases [TACTIC]
- Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs
WBRT alone on neurological progression-free survival at 2 months in patients with
advanced non-small cell lung cancer and multiple brain metastases.
- Compare the toxicity of these regimens.
- Compare the response rate in these patients.
- Compare quality of life of these patients.
- Compare change in performance status in these patients.
- Compare steroid dosing in these patients.
- Compare sites of progression (cranial or extracranial) in these patients.
OUTLINE: This is a multicenter study. Patients are stratified by presence of extracranial
metastases (yes vs no), RTOG recursive partitioning analysis (RPA) score (I vs II) and
treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily for 5 days. Patients
also receive oral erlotinib hydrochloride once daily for up to 24 months.
- Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once
daily for up to 24 months.
Quality of life is assessed at baseline, monthly for 12 months, and then at 18 and 24
After completion of study therapy, patients are followed every 1-2 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Neurological progression-free survival at 2 months
at 2 months
Siow M. Lee, MD, PhD, FRCP
University College London Hospitals
United Kingdom: Medicines and Healthcare Products Regulatory Agency