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NCT05709782 | Recruiting | Spinal Disease

Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
Sponsor:

M.D. Anderson Cancer Center

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.

Condition or disease

Spinal Disease

Intervention/treatment

Spine Radiosurgery

Magnetic Resonance imaging

MR-LINAC

Phase

Phase 2

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}}

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
Actual Study Start Date : May 9, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2026
Arm Intervention/treatment

Experimental: Group 1 (Therapeutic Cohort)

Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

Procedure: Spine Radiosurgery

Device: Magnetic Resonance imaging

Experimental: Group 2 (Imaging-only Cohort)

Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.

Radiation: MR-LINAC

Procedure: Spine Radiosurgery
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

Location Details

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Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030