Recruiting
Phase 2

Radiotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05709782

Conditions

Spinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spine Radiosurgery

Magnetic Resonance imaging

MR-LINAC

Study Details

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.

Conditions

Spinal Disease

Study ID

NCT05709782

Start date

May 9, 2023

Status verified date

Jul, 2026

Completion date

Jan 13, 2029

Anticipated

Primary completion date

Jan 13, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Spine Radiosurgery

scan

Magnetic Resonance imaging

scan

MR-LINAC

scan

Primary outcome measure

  • M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires [ Time Frame: through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Debra N. Yeboa, MD

(713) 563-2415dnyeboa@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Debra Yeboa, MD

713-563-2415dnyeboa@mdanderson.org

Principal Investigator:

Debra N. Yeboa, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-21.