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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Spinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Spine Radiosurgery

Intervention Type PROCEDURE

scan

Magnetic Resonance imaging

Intervention Type DEVICE

scan

MR-LINAC

Intervention Type RADIATION

scan

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.

Group Type EXPERIMENTAL

Spine Radiosurgery

Intervention Type PROCEDURE

scan

Magnetic Resonance imaging

Intervention Type DEVICE

scan

Interventions

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Spine Radiosurgery

scan

Intervention Type PROCEDURE

Magnetic Resonance imaging

scan

Intervention Type DEVICE

MR-LINAC

scan

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No