Brain Metastases Study: Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases
|Neoplasm Metastasis Brain Neoplasms||Procedure: Radiotherapy, dose fractionation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases|
- Progression free survival
- Quality of life
- Cost effectiveness
- Neurological functioning
|Study Start Date:||February 1996|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Untreated brain metastases are usually fatal within a few weeks. The standard treatment for brain metastases is whole brain irradiation. This results on average in an increase in survival by 2 to 4 times compared to withholding irradiation. The majority of patients experience improvement in the level of functioning as a result of irradiation. None-the-less approximately half of patients die because of progression of the brain metastases and their quality of life is often dominated by the effects of brain metastases.
Various different dosages of radiation have been assessed and we wish to further investigate this by comparing a less intense schema with a more intense schema. Both of these fall within the range of published experience but have not been directly compared. The more intense schema may have more effect on the tumour but previous variations of dose intensity have not shown significant differences in survival. Differences in control of the metastases in the brain have been suggested but there have been no good comparisons of quality of life. Obviously when survival is measured on average in only 3 to 6 months, this is an important parameter for comparison.
Comparisons: Stratification is by diagnosis either excision or biopsy/clinical. Patients will be randomised to receive either 40Gy 20#bd or 20Gy 4#daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138788
|Australia, New South Wales|
|Cancer Care Centre, St George Hospital|
|Sydney, New South Wales, Australia, 2217|
|Principal Investigator:||Associate Professor Peter H Graham||Cancer Care Centre, St George Hospital, Sydney, Australia|