Clinical trial NCT00138788: Brain Metastases Study: Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases
Official title: To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasm Metastasis
Brain Neoplasms
Keywords: Radiotherapy
Qualify of life
Neoplasm metastasis of the brain
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a comparison of radiotherapy fractionation schemes for brain metastasis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ECOG performance status 0 - 2.
* Brain metastasis. Brain biopsy not obligatory if known previous malignancy and multiple lesions typical on computed tomography (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

Primary outcomes:
measure: Progression free survival
measure: Quality of life
Secondary outcomes:
measure: Cost effectiveness
measure: Toxicity
measure: Neurological functioning
measure: Survival
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Cancer Care Centre, St George Hospital
state: New South Wales
Study officials:
affiliation: Cancer Care Centre, St George Hospital, Sydney, Australia
name: Associate Professor Peter H Graham
role: PRINCIPAL_INVESTIGATOR
References: