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

This study has been completed.
Sponsor:
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00138788
First received: August 29, 2005
Last updated: November 19, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138788

Locations
Australia, New South Wales
Cancer Care Centre, St George Hospital
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Investigators
Principal Investigator: Associate Professor Peter H Graham Cancer Care Centre, St George Hospital, Sydney, Australia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138788     History of Changes
Other Study ID Numbers: 95/29 Graham
Study First Received: August 29, 2005
Last Updated: November 19, 2008
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013