Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
ConditionSpinal Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Spine Radiosurgery
Procedure/Surgeryscan
Magnetic Resonance imaging
Devicescan
MR-LINAC
Radiationscan
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1 (Therapeutic Cohort)Experimental treatment 3 interventions
Group B: Group 2 (Imaging-only Cohort)Experimental treatment 2 interventions
Trial outcomes
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.
Time frame
through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov