Lung Cancer Clinical Trial
Official title:
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]
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib
may also make tumor cells more sensitive to radiation therapy. It is not yet known whether
giving whole-brain radiation therapy together with erlotinib is more effective than
whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and
brain metastases.
PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and
erlotinib to see how well they work compared with whole-brain radiation therapy alone in
treating patients with advanced non-small cell lung cancer and brain metastases.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
months.
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
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