Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

Recruiting now · Not applicable

Conditions studied: Brain Metastases, Adult

In brief

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.

Key facts

Study ID

NCT05124236

Run by

Susanne Rogers

People needed

200

Starts

2022-07-29

Expected to finish

2028-12-30

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
• >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
• Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
• 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
• Unable to tolerate radiosurgery immobilization and treatment
• Inability to give informed consent
• Pregnancy or lactation
• 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
• Lack of likely compliance with protocol and follow-up

Where it is running

• Kantonsspital Winterthur — Winterthur, Switzerland (enrolling)
• Knappschaft Kliniken, Universitätsklinikum Bochum GmbH — Bochum, Germany (enrolling)
• UKGM-Giessen — Giessen, Germany (enrolling)
• Universitätsklinikum Schleswig Holstein — Kiel, Germany (enrolling)
• Kantonsspital Aarau — Aarau, Canton of Aargau, Switzerland (enrolling)
• Inselspital, Universitätsklinik für Radio-Onkologie — Bern, Freiburgstrasse, Switzerland (enrolling)
• Kantonsspital Graubünden — Chur, Switzerland (enrolling)
• Luzerner Kantonsspital — Lucerne, Switzerland (enrolling)
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland (enrolling)
• Tirol Kliniken Innsbruck — Innsbruck, Austria

Full record on ClinicalTrials.gov

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