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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138788
• Other study ID #: 95/29 Graham
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: November 19, 2008
• Start date: February 1996
• Est. completion date: March 2007

Study information

• Verified date: November 2008
• Source: St George Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Radiotherapy, dose fractionation

Locations

Country	Name	City	State
Australia	Cancer Care Centre, St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival
Primary	Quality of life
Secondary	Cost effectiveness
Secondary	Toxicity
Secondary	Neurological functioning
Secondary	Survival