Spinal Disease
Conditions
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.
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
Interventions
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTDebra N. Yeboa, MD
PRINCIPAL_INVESTIGATORDebra N. Yeboa, MD
M.D. Anderson Cancer Center
Outcome results
None listed