WBRT & Erlotinib in Advanced NSCLC and 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.
Drug: erlotinib hydrochloride
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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]|
- Neurological progression-free survival at 2 months [ Time Frame: at 2 months ]
- Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment. ]
- Response rate [ Time Frame: from date of randomisation to radiological progression ]
- Quality of life [ Time Frame: completed monthly for the first 12 months and at 18 and 24 months from randomisation ]
- Change in performance status [ Time Frame: from baseline ]
- Steroid dosing [ Time Frame: from baseline ]
- Sites of progression (cranial or extracranial) [ Time Frame: from baseline ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: erlotinib hydrochloride
WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Drug: erlotinib hydrochloride
PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Placebo Comparator: placebo
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride
- 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 months.
After completion of study therapy, patients are followed every 1-2 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554775
|Charing Cross Hospital|
|London, England, United Kingdom, W6 8RF|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Manchester, England, United Kingdom, M20 4BX|
|Salisbury District Hospital|
|Salisbury, England, United Kingdom, SP2 8BJ|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Glan Clwyd Hospital|
|Rhyl, Denbighshire, Wales, United Kingdom, LL18 5UJ|
|South West Wales Cancer Institute|
|Swansea, Wales, United Kingdom, SA2 8QA|
|Study Chair:||Siow M. Lee, MD, PhD, FRCP||University College London Hospitals|