Radiation before or after surgery for brain metastases that can be removed
Compares radiation given before versus after surgery in adults with brain metastases.
Key facts
- Who runs it
- Susanne Rogers
- Where
- Austria, Germany, and Switzerland10 sites in 3 countriesChoose a country to see its sites
- Trial code
- Registry title
- Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 29 Jul 2022
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- preoperative radiosurgery
- postoperative hypofractionated stereotactic radiotherapy
- Record updated
- 4 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a brain metastasis (cancer spread to the brain) planned for surgery. It compares one radiosurgery session before surgery with 5 sessions of radiotherapy after surgery.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- One clearly outlined brain metastasis up to 4.0 cm (1.6 in) across, planned for surgical removal by a tumour board. Up to 3 other brain metastases that can be treated with radiosurgery are allowed. Karnofsky performance status of 60 or more. Expected survival of more than 12 months.
- Earlier treatment
- No prior radiation to the brain. No prior surgery for a brain tumour. No radionuclide therapy within 30 days. No anti-VEGF therapy within 6 weeks.
- Biomarker or test result
- Tissue diagnosis of a malignant tumour. Platelet count > 100/ml, INR < 1.3, Hb > 7.5 g/dL.
Main reasons for not taking part
- Germ cell tumour, lymphoma or multiple myeloma
- More than 4 brain metastases, more than 1 needing surgery, or the one for surgery larger than 4.0 cm (1.6 in)
- Raised pressure in the skull needing urgent surgery, or midline shift over 10 mm
- Cancer spread to the brain lining or spinal fluid, unless limited and treatable
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥18
- Karnofsky performance status ≥60
- Histological diagnosis of a malignant primary or metastatic tumour
- Ability to take steroids
- No contraindication to magnetic resonance imaging (MRI)
- MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other brain metastases suitable for primary radiosurgery/ stereotactic radiotherapy
- Survival estimated by primary clinician > 12 months
- Platelet count > 100/ml, INR < 1.3, Hb > 7.5 g/dL
Who cannot take part
- >10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
- More than 4 brain metastases or the diameter of the metastasis for resection >4.0 cm
- More than 1 metastasis requiring resection
- Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
- Prior resection of a primary or secondary brain tumor
- Prior diagnosis of a non-meningioma brain tumor
- Prior radionuclide therapy within 30 days
- Prior anti-VEGF therapy within 6 weeks
- Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy
- Males of reproductive potential not effective contraception for 3 months after radiotherapy
- Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
- Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
- Unable to tolerate radiosurgery immobilization and treatment
- Inability to give informed consent
- Pregnancy or lactation
- Lack of likely compliance with protocol and follow-up
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.
The 2 groups in the trial
- Preoperative radiosurgeryTreatment being tested
The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection.
- Postoperative hypofractionated stereotactic radiotherapyExisting treatment, for comparison
The active comparator arm is the standard of care of postoperative hypofractionated stereotactic radiotherapy to the surgical cavity in 5 fractions following resection of the brain metastasis.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
- Plain-language title
- Radiation before or after surgery for brain metastases that can be removedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 4 March 2026