MRIdian "RADAR" Trial

Launched by UNIVERSITY OF MIAMI · Oct 4, 2023

Keywords

ClinConnect Summary

The MRIdian "RADAR" Trial is a clinical study designed to explore a new way to treat certain types of cancer that cause pressure on the spinal cord, known as metastatic epidural spinal cord compression (MESCC). This trial will investigate whether a special type of radiation therapy, guided by magnetic resonance imaging (MRI), can help control tumors and possibly eliminate the need for surgery. The researchers hope that this approach will be effective in treating cancers such as breast, prostate, and lung cancer, among others.

To participate in the trial, individuals must be at least 18 years old and have solid tumors causing MESCC for which surgery could be an option. Participants should be able to walk and have a good performance status, meaning they can carry out everyday activities. Those with mild to moderate nerve issues that have improved with medication may also qualify. Throughout the study, participants will receive daily MRI scans to monitor their treatment. If you're considering participating, it's important to know that those with certain rapid neurological changes or prior radiation to the treatment area will not be eligible.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female participants ages ≥ 18.
• • 2. Solid tumors causing MESCC for which surgery is an option as first-line treatment.
• • 3. Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria.
• • 4. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
• • 5. Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI.
• • 6. Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels.
• • 7. Karnofsky performance score ≥60
• • 8. Survival prognosis ≥3 months
• • 9. Medical status allowing surgery.
• • 10. Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression.
• • 11. Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
• • 12. All patients must be ambulatory.
• • 13. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment)
• • 14. Spine instability neoplastic score \< 14
• • a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.
• • 15. Willing and able to undergo daily MRI during treatment
• • 16. Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy.
• • 17. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• • 18. History and physical within 2 weeks prior to registration
• • 19. Patients must provide study specific informed consent prior to study entry.
• Exclusion Criteria:
• • 1. Unknown primary histology
• • 2. Patients with rapid neurologic decline.
• • 3. Bony retropulsion causing neurologic abnormality
• • 4. Non-ambulatory patients.
• • 5. Prior radiation to the involved site.
• • 6. Inability to have an MRI
• • 7. Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases)
• • 8. Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma)
• • 9. Patients with impaired decision-making capacity.