NCT05124236 Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
| NCT ID | NCT05124236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Susanne Rogers |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-07-29 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-07-29 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 brain metastases or the diameter of the metastasis for resection \>4.0 cm. 4. More than 1 metastasis requiring resection 5. Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis) 6. Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT) 7. Prior resection of a primary or secondary brain tumor 8. Prior diagnosis of a non-meningioma brain tumor 9. Prior radionuclide therapy within 30 days 10. Prior anti-VEGF therapy within 6 weeks 11. Unable to tolerate radiosurgery immobilization and treatment 12. Inability to give informed consent 13. Pregnancy or lactation 14. Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy 15. Males of reproductive potential not effective contraception for 3 months after radiotherapy 16. Lack of likely compliance with protocol and follow-up
Contact & Investigator
Susanne Rogers, MD PhD
PRINCIPAL INVESTIGATOR
Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland
Frequently Asked Questions
Who can join the NCT05124236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05124236 currently recruiting?
Yes, NCT05124236 is actively recruiting participants. Contact the research team at Susanne.rogers@ksa.ch for enrollment information.
Where is the NCT05124236 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Bochum, Germany, Giessen, Germany, Kiel, Germany and 6 additional locations.
Who is sponsoring the NCT05124236 clinical trial?
NCT05124236 is sponsored by Susanne Rogers. The principal investigator is Susanne Rogers, MD PhD at Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland. The trial plans to enroll 200 participants.