To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Associate Professor Peter H Graham
Principal Investigator
Cancer Care Centre, St George Hospital, Sydney, Australia
Australia: Human Research Ethics Committee
95/29 Graham
NCT00138788
February 1996
March 2007
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