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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Spinal Disease

Treatments: Radiation: MR-LINAC; Device: Magnetic Resonance imaging; Procedure: Spine Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05709782

NCI-2023-00663 (Other Identifier)

2022-0589

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group 1 (Therapeutic Cohort)

Experimental group

Description:

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

Treatment:

Procedure: Spine Radiosurgery

Radiation: MR-LINAC

Device: Magnetic Resonance imaging

Group 2 (Imaging-only Cohort)

Experimental group

Description:

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.

Treatment:

Procedure: Spine Radiosurgery

Device: Magnetic Resonance imaging