Know Cancer

forgot password

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

Phase 3
18 Years
Not Enrolling
Neoplasm Metastasis, Brain Neoplasms

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Principal Investigator

Associate Professor Peter H Graham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Care Centre, St George Hospital, Sydney, Australia


Australia: Human Research Ethics Committee

Study ID:

95/29 Graham



Start Date:

February 1996

Completion Date:

March 2007

Related Keywords:

  • Neoplasm Metastasis
  • Brain Neoplasms
  • Radiotherapy
  • Qualify of life
  • Neoplasm metastasis of the brain
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary