Clinical trial NCT06077071: MRIdian "RADAR" Trial
Official title: MRIdian "RADAR" Trial - Radiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression Using Stereotactic MRI-guided Adaptive Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metastatic Epidural Spinal Cord Compression
Spinal Cord Compression
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Viewray Inc.
First posted: 2023-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).


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.

Primary outcomes:
measure: One-year failure rate
timeFrame: Up to 1 year
Secondary outcomes:
measure: Rate of radiation myelopathy
timeFrame: Up to 6 months
measure: Rate of vertebral compression fracture
timeFrame: Up to 2 years
measure: Number of Treatment Related Adverse Events as Measured By CTCAE v.5
timeFrame: Up to 1 year
measure: Local control (LC) rate
timeFrame: Up to 10 weeks
measure: Local progression (LP) rate
timeFrame: Up to 10 weeks
measure: Change in mean relative in epidural tumor
timeFrame: Baseline, Up to 10 weeks
measure: Overall epidural tumor response rate
timeFrame: Up to 10 weeks
measure: Change in mean relative thecal sac patency
timeFrame: Baseline, Up to 10 weeks
measure: Change in thecal sac decompression rate
timeFrame: Baseline, Up to 14 weeks
measure: In-field progression (IFP) rate
timeFrame: Up to 1 year
measure: Distant progression (DP) rate
timeFrame: Up to 1 year
measure: Failure-Free Survival (FFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Quality of Life Assessed Using EuroQol (EQ) Five Dimension (5D) Five Level (5L) (EQ-5D-5L)
timeFrame: Up to 2 years
measure: Quality of Life Assessed Using FACT-G
timeFrame: Up 2 years
measure: Local Pain Control as Measured by Brief Pain Inventory (BPI)
timeFrame: Up to 2 years
measure: Rate of ambulation preservation
timeFrame: Up to 2 years
measure: Maximum planned target volume (PTV) maximum dose (Dmax)
timeFrame: Up to 1 year
measure: Mean planned target volume (PTV) Dose Mean (DMean)
timeFrame: Up to 1 year
measure: PTV D80
timeFrame: Up to 1 year
measure: PTV D95
timeFrame: Up to 1 year
measure: Spinal cord Dmax
timeFrame: Up to 1 year
measure: Spinal cord D0.03
timeFrame: Up to 1 year
measure: Spinal cord D0.1
timeFrame: Up to 1 year
measure: Spinal cord D1
timeFrame: Up to 1 year
measure: Spinal cord D50
timeFrame: Up to 1 year
measure: Area under the curve (AUC) for receiving operating characteristic analysis
timeFrame: Up to 1 year
measure: Dice's coefficient
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Benjamin Spieler, MD
role: PRINCIPAL_INVESTIGATOR
References: