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

Phase 2

Recruiting

• Conditions: Spinal Disease
• Interventions: Procedure: Spine Radiosurgery; Device: Magnetic Resonance imaging; Radiation: MR-LINAC

• Registration Number: NCT05709782
• Lead 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.

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 Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Study Start: 2023-05-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1 (Therapeutic Cohort)	Spine Radiosurgery	Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
Group 2 (Imaging-only Cohort)	Spine Radiosurgery	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.
Group 2 (Imaging-only Cohort)	Magnetic Resonance imaging	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.
Group 1 (Therapeutic Cohort)	MR-LINAC	Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
Group 1 (Therapeutic Cohort)	Magnetic Resonance imaging	Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States