Recruiting
Phase 2

Spine Stereotactic Radiosurgery

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06204315

Conditions

Spinal Cord

Metastatic Epidural

Spine Stereotactic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiosurgery

Study Details

Brief summary:

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Conditions

Spinal Cord

Metastatic Epidural

Spine Stereotactic

Study ID

NCT06204315

Start date

Nov 11, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Greater than or equal to 18 years old
2. Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
3. Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
4. All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
5. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
6. All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
7. All participants must have a vertebral level site of interest from C1 to S2
8. Signed informed consent
9. Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
10. Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
11. ECOG ≤ 2

Exclusion Criteria:

1. Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
2. Prior history of radiation at the spinal site of interest
3. Inability to lie supine comfortably for ≥ 60 minutes
4. Progressive neurological deficits due to compression
5. Inability of obtain an MRI
6. Inability or refusal to undergo an MR simulation
7. No eligible for single fraction SSRS for any reason
8. Participants who are pregnant

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Stereotactic Radiosurgery

A non-invasive, non-surgical procedure that precisely delivers radiation to cancer on the spine while avoiding surrounding, healthy tissue.

Interventions

Stereotactic Radiosurgery

Given by RTx

Primary outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Amol Ghia, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.