WBRT & Erlotinib in Advanced NSCLC and Brain Metastases
- Conditions
- Lung CancerMetastatic Cancer
- Interventions
- Drug: placebo
- Registration Number
- NCT00554775
- Lead Sponsor
- University College, London
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description erlotinib hydrochloride 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 placebo placebo WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm
- Primary Outcome Measures
Name Time Method Neurological progression-free survival at 2 months at 2 months
- Secondary Outcome Measures
Name Time Method Toxicity during and for 28 days following Tarceva/placebo treatment. Response rate from date of randomisation to radiological progression Quality of life completed monthly for the first 12 months and at 18 and 24 months from randomisation Change in performance status from baseline Steroid dosing from baseline Sites of progression (cranial or extracranial) from baseline
Trial Locations
- Locations (7)
University College of London Hospitals
🇬🇧London, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom