Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
Study Details
Study Description
Brief Summary
To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Primary objective:
• To determine the 6-month local control (LC) of the target site of treatment.
Secondary Objectives:
-
To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
-
To determine the 1-year local control of the target site
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (Therapeutic Cohort) Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine. |
Procedure: Spine Radiosurgery
scan
Device: Magnetic Resonance imaging
scan
Radiation: MR-LINAC
scan
|
| Experimental: Group 2 (Imaging-only Cohort) Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC. |
Procedure: Spine Radiosurgery
scan
Device: Magnetic Resonance imaging
scan
|
Outcome Measures
Primary Outcome Measures
- M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires [through study completion; an average of 1 year]
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
-
Age ≥ 18 years old
-
Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
-
Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
-
Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
-
Diagnosis of cancer documented
-
Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
-
Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3
EXCLUSION CRITERIA:
-
Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
-
Patients who are unable to undergo MRI of the spine with contrast
-
Patients who are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Debra N. Yeboa, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0589
- NCI-2023-00663