Brain Metastases Study: Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases

Phase 3

Completed

• Conditions: Neoplasm Metastasis; Brain Neoplasms

• Registration Number: NCT00138788
• Lead Sponsor: St George Hospital, Australia

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.

Study Timeline

• Study Start: 1996-02
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-19
• Last Update Posted: 2008-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression free survival
Quality of life

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness
Toxicity
Neurological functioning
Survival

Trial Locations

Locations (1)

Cancer Care Centre, St George Hospital; 🇦🇺 Sydney, New South Wales, Australia