Status:
COMPLETED
A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
Lead Sponsor:
Royal Adelaide Hospital
Conditions:
Neoplasm Metastasis
Brain Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
Primary objectives - to evaluate for solitary brain metastases whether both overall survival and health related quality of life (HQoL) in patients treated with radiosurgery (RS) plus whole brain radio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00124761
Start Date
December 1 2002
End Date
May 1 2009
Last Update
September 6 2010
Active Locations (1)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000