Brain Metastases Study

Purpose- Comparison of radiotherapy fractionation schemes for brain metastasis.

Official Title

To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Further Details

Primary Outcomes: Control of disease; Quality of lifeSecondary Outcomes: Cost effectiveness; Toxicity; Neurological functioning; SurvivalUntreated 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 20bd or 20Gy 4xdaily.

Study Start

Study start: February 1996; Expected completion: December 2008; Last follow-up: July 2007; Data en

Eligibility & Criteria

Ages Eligible for Study: 18 Years and aboveGenders Eligible for Study: Both CriteriaInclusion Criteria:- ECOG Performance status 0 – 2. – Brain metastasis. Brain biopsy not obligatory if known previous malignancy and multiple lesions typical on CT scan of brain. Solitary lesions if suitably located should be biopsied and preferably excised. – Extracranial disease stable or absent (i.e. no progression over 2 months) OR concurrent presentation of brain metastasis and extracranial disease at time of initial cancer diagnosis. – Able to consent – Life expectancy exceeds 2 months

Total Enrolment

Expected Total Enrollment: 112

Contact Details

Australia, New South WalesCancer Care Centre, St George Hospital, Sydney, New South Wales, 2217, Australia; Recruiting Associate Prof. Peter H Graham, MBBS FRANZCR +61 2 9350-3912 GrahamP@sesahs.nsw.gov.au Associate Prof. Peter H Graham, MBBS FRANZCR, Principal Investigator