Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00138788




Registration number
NCT00138788
Ethics application status
Date submitted
29/08/2005
Date registered
30/08/2005
Date last updated
20/11/2008

Titles & IDs
Public title
Brain Metastases Study: Radiotherapy Fractionation Schemes in the Treatment of Brain Metastases
Scientific title
To Determine Which of Two Radiotherapy Brain Fractionation Schemes is Superior in the Treatment of Brain Metastases
Secondary ID [1] 0 0
95/29 Graham
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Brain Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Radiotherapy, dose fractionation

Treatment: Surgery: Radiotherapy, dose fractionation
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
Primary outcome [2] 0 0
Quality of life
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Cost effectiveness
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Toxicity
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Neurological functioning
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Survival
Timepoint [4] 0 0

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cancer Care Centre, St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a comparison of radiotherapy fractionation schemes for brain metastasis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00138788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Associate Professor Peter H Graham
Address 0 0
Cancer Care Centre, St George Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00138788