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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-02-29

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Neoplasm Metastasis Brain Neoplasms

Keywords

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Radiotherapy Qualify of life Neoplasm metastasis of the brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Radiotherapy, dose fractionation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Associate Professor Peter H Graham

Role: PRINCIPAL_INVESTIGATOR

Cancer Care Centre, St George Hospital, Sydney, Australia

Locations

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Cancer Care Centre, St George Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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95/29 Graham

Identifier Type: -

Identifier Source: org_study_id