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

Primary Purpose

Neoplasm Metastasis, Brain Neoplasms

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Radiotherapy, dose fractionation
Sponsored by
St George Hospital, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Radiotherapy, Qualify of life, Neoplasm metastasis of the brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Care Centre, St George Hospital

Outcomes

Primary Outcome Measures

Progression free survival
Quality of life

Secondary Outcome Measures

Cost effectiveness
Toxicity
Neurological functioning
Survival

Full Information

First Posted
August 29, 2005
Last Updated
November 19, 2008
Sponsor
St George Hospital, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00138788
Brief Title
Brain Metastases Study: Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases
Official Title
To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 1996 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St George Hospital, Australia

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Brain Neoplasms
Keywords
Radiotherapy, Qualify of life, Neoplasm metastasis of the brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Radiotherapy, dose fractionation
Primary Outcome Measure Information:
Title
Progression free survival
Title
Quality of life
Secondary Outcome Measure Information:
Title
Cost effectiveness
Title
Toxicity
Title
Neurological functioning
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Professor Peter H Graham
Organizational Affiliation
Cancer Care Centre, St George Hospital, Sydney, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Care Centre, St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia

12. IPD Sharing Statement

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

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