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Completed

NCT Number: NCT00138788

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Care Centre, St George Hospital

Sydney, New South Wales, 2217, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy, dose fractionation

Procedure

Primary outcomes

  1. Progression free survival

  2. Quality of life

Secondary outcomes

  1. Cost effectiveness

  2. Toxicity

  3. Neurological functioning

  4. Survival

Sponsors and collaborators

Lead sponsor

St George Hospital, Australia

Other

Registry information

Official study title

To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases

Important dates

Study start
1996
Primary completion
2007
Study completion
2007
First posted
Aug 30, 2005
Registry last updated
Nov 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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