Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spine Radiosurgery, Magnetic Resonance imaging, MR-LINAC.
- Who it may be relevant to
- Registry conditions: Spinal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure Spine Radiosurgery
scan - Device Magnetic Resonance imaging
scan - Radiation MR-LINAC
scan
Primary outcome measures
- M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires [Time frame: through study completion; an average of 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05709782 · 2022-0589 · NCI-2023-00663