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Recruiting NCT05124236

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

Trial Parameters

Condition Brain Metastases, Adult
Sponsor Susanne Rogers
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-07-29
Completion 2028-12-30
Interventions
preoperative radiosurgerypostoperative hypofractionated stereotactic radiotherapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age ≥18 4. Karnofsky performance status ≥60 5. Histological diagnosis of a malignant primary or metastatic tumour 6. Ability to take steroids 7. No contraindication to magnetic resonance imaging (MRI) 8. 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 9. Survival estimated by primary clinician \> 12 months 10. Platelet count \> 100/ml, INR \< 1.3, Hb \> 7.5 g/dL Exclusion Criteria: 1. Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma 2. \>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery 3. More than 4

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