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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00124761




Registration number
NCT00124761
Ethics application status
Date submitted
27/07/2005
Date registered
28/07/2005
Date last updated
6/09/2010

Titles & IDs
Public title
A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
Scientific title
A Randomised Trial of Surgery Plus Whole Brain Radiotherapy (WBRT) Versus Radiosurgery Plus WBRT for Solitary Brain Metastases
Secondary ID [1] 0 0
021108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Brain Neoplasm 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 - Surgery + WBRT
Treatment: Other - Radiosurgery + WBRT

Other: Surgery + Whole Brain Radiotherapy -

Experimental: RadioSurgery + Whole Brain Radiotherapy -


Treatment: Surgery: Surgery + WBRT
Surgery - complete excision of Solitary Brain Metastasis with 30 Gy in 10 fractions over 2 2 1/2 weeks

Treatment: Other: Radiosurgery + WBRT
Radiosurgery - Marginal dose based on maximum tumour diameter

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival and Quality of life
Timepoint [1] 0 0
Until death or study completion
Secondary outcome [1] 0 0
Local and distant recurrence
Timepoint [1] 0 0
Until death or study completion
Secondary outcome [2] 0 0
Failure free survival
Timepoint [2] 0 0
Until death or study completion
Secondary outcome [3] 0 0
Acute and late toxicities
Timepoint [3] 0 0
Acute toxicities 6 weeks post RT and late toxicities until death

Eligibility
Key inclusion criteria
- Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan
within two weeks before commencement of treatment.

- Systemic cancer diagnosed histologically or cytologically synchronous with, or within
5 years of treatment of the presumed brain metastasis (other than non-melanoma skin
cancer and cancer in-situ of the cervix, neither of which would be reasonably
attributable as the primary site). Exception - melanoma diagnosed > 5 years previously
is allowable in view of the extremely variable natural history of melanoma.

- Age >= 18 (no upper age limit).

- Considered suitable for both S and RS by the neurosurgeon and radiation oncologist
(see exclusions).

- Patient must agree to adjuvant WBRT.

- RTOG RPA Class 1 or 2 (Karnofsky Performance Status [KPS] >= 70 after adequate trial
of corticosteroids).

- RPA Class 3 patients (KPS < 70) eligible if it is considered that the poor performance
status is due primarily to the solitary metastasis, aggressive local treatment of
which may be expected to restore good performance status. This would ordinarily be
associated with minimal systemic disease burden.

- Accessible for treatment and follow-up.

- Patient is infertile or is aware of the risk of becoming pregnant or fathering
children and will use adequate contraception.

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous history of brain metastasis(es)

- Surgery indicated to relieve life-threatening raised intracranial pressure or excision
required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary).
However, prior diagnostic (non-excisional) biopsy is allowable - it is acknowledged
that the 50% probability of a repeat surgical procedure on subsequent randomisation
would not be acceptable to many patients and clinicians.

- Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities.

- Leptomeningeal disease.

- Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma.

- Prior cranial RT (including RS).

- Patient is pregnant.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Adelaide Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment
of cancer which has spread to one spot in the brain (solitary brain "metastasis"). For these
two treatment options, it will compare patients' survival times, quality of life, control
rate of the brain metastases and side effects. It uses the most rigorous scientific method
available called "randomisation" which minimises biases that exist with other types of
studies. It will involve 30 - 40 patients.
Trial website
https://clinicaltrials.gov/show/NCT00124761
Trial related presentations / publications
Roos DE, Brophy BP, Zavgorodni SF, Katsilis ES. Radiosurgery for brain metastases at the Royal Adelaide Hospital: are we treating the right patients? Australas Radiol. 2002 Dec;46(4):402-8.
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Roos, MD, FRANZCR
Address 0 0
Royal Adelaide Hospital
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
Other publications