Clinical trial · Interventional
A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases
A Randomised Trial of Surgery Plus Whole Brain Radiotherapy (WBRT) Versus Radiosurgery Plus WBRT for Solitary Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiosurgery + WBRT | Radiation | — | UNRESOLVED |
| Surgery + WBRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Surgery + Whole Brain Radiotherapy
- interventionNames
- Procedure: Surgery + WBRT
- type
- EXPERIMENTAL
- label
- RadioSurgery + Whole Brain Radiotherapy
- interventionNames
- Radiation: Radiosurgery + WBRT
Primary outcomes (1)
- measure
- Overall survival and Quality of life
- timeFrame
- Until death or study completion
Secondary outcomes (3)
- measure
- Local and distant recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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.
References
Publications (2)
- BACKGROUNDRoos 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. doi: 10.1046/j.1440-1673.2002.t01-1-01094.x. PMID 12452912
- DERIVEDRoos DE, Smith JG, Stephens SW. Radiosurgery versus surgery, both with adjuvant whole brain radiotherapy, for solitary brain metastases: a randomised controlled trial. Clin Oncol (R Coll Radiol). 2011 Nov;23(9):646-51. doi: 10.1016/j.clon.2011.04.009. Epub 2011 May 17. PMID 21592754