Spots Global Cancer Trial Database for WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

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Trial Identification

Brief Title: WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

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]

Study ID: NCT00554775

Conditions

Lung Cancer

Metastatic Cancer

Interventions

erlotinib hydrochloride

placebo

Study Description

Brief Summary: 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.

Detailed Description: 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.