Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedJanuary 14, 2026
January 1, 2026
2.7 years
January 24, 2023
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
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.
through study completion; an average of 1 year
Study Arms (2)
Group 1 (Therapeutic Cohort)
EXPERIMENTALParticipants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
Group 2 (Imaging-only Cohort)
EXPERIMENTALParticipants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra N. Yeboa, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2023
First Posted
February 2, 2023
Study Start
May 9, 2023
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01