NCT05709782PHASE2Recruiting
Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
M.D. Anderson Cancer Center
Start Date
5/9/2023
Completion Date
1/13/2029
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.
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
Eligibility Criteria
Age Range: 18 years to No maximum
INCLUSION CRITERIA:
1. Age ≥ 18 years old
2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
5. Diagnosis of cancer documented
6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3
EXCLUSION CRITERIA:
1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
2. Patients who are unable to undergo MRI of the spine with contrast
3. Patients who are pregnant
Interventions
PROCEDURE
Spine Radiosurgery
DEVICE
Magnetic Resonance imaging
RADIATION
MR-LINAC
Conditions
Spinal Disease
Locations
M D Anderson Cancer Center
Houston, Texas 77030
United States