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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138788
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 20, 2008
Information provided by:
St George Hospital, Australia

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

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Brain Neoplasms Procedure: Radiotherapy, dose fractionation Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
Study Start Date : February 1996
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. Progression free survival
  2. Quality of life

Secondary Outcome Measures :
  1. Cost effectiveness
  2. Toxicity
  3. Neurological functioning
  4. Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00138788     History of Changes
Other Study ID Numbers: 95/29 Graham
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: November 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