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

This study has been completed.
Information provided by:
St George Hospital, Australia Identifier:
First received: August 29, 2005
Last updated: November 19, 2008
Last verified: November 2008
This is a comparison of radiotherapy fractionation schemes for brain metastasis.

Condition Intervention Phase
Neoplasm Metastasis
Brain Neoplasms
Procedure: Radiotherapy, dose fractionation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases

Further study details as provided by St George Hospital, Australia:

Primary Outcome Measures:
  • Progression free survival
  • Quality of life

Secondary Outcome Measures:
  • Cost effectiveness
  • Toxicity
  • Neurological functioning
  • Survival

Estimated Enrollment: 112
Study Start Date: February 1996
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00138788

Australia, New South Wales
Cancer Care Centre, St George Hospital
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Principal Investigator: Associate Professor Peter H Graham Cancer Care Centre, St George Hospital, Sydney, Australia
  More Information Identifier: NCT00138788     History of Changes
Other Study ID Numbers: 95/29 Graham
Study First Received: August 29, 2005
Last Updated: November 19, 2008

Keywords provided by St George Hospital, Australia:
Qualify of life
Neoplasm metastasis of the brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 28, 2017