Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138788
Status:
COMPLETED
Last Update Posted:
2008-11-20
First Post:
2005-08-29
Brief Title:
Brain Metastases Study Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases
Sponsor:
St George Hospital Australia
Organization:
St George Hospital Australia
Study Overview
Official Title:
To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 biopsyclinical Patients will be randomised to receive either 40Gy 20bd or 20Gy 4daily
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 biopsyclinical Patients will be randomised to receive either 40Gy 20bd or 20Gy 4daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None