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

Launched by SUSANNE ROGERS · Nov 13, 2021

Keywords

ClinConnect Summary

This clinical trial is examining two different methods of radiation treatment for adults with brain metastases, which are cancerous tumors that have spread to the brain. The main question is whether a single dose of radiation given before surgery can lower the chances of developing a specific type of disease in the brain 12 months after the tumor is removed, compared to receiving multiple doses of radiation after surgery. Researchers are currently looking for participants aged 18 and older who have a certain type of brain tumor that is suitable for surgical removal and meet other health criteria.

If you or a loved one qualifies for this study, you will be asked to sign a consent form, and you'll need to be available for various study procedures. Participants will either receive the pre-surgery radiation treatment or the post-surgery treatment and be monitored over time. It’s important to note that there are specific health requirements and conditions that might exclude someone from participating, such as having certain types of tumors or prior radiation treatment. Overall, this trial aims to find out which treatment approach is more effective in preventing complications after surgery.

Gender

ALL

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