Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

NCT06204315 | Recruiting Phase 2 DMC

• 2 other identifiers: 2023-0287NCI-2024-00049
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Stereotactic Radiosurgery

EXPERIMENTAL

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

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Given by RTx

Also known as: CDE-SSRS

Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years old
• Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
• Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
• 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.
• Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
• 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
• All participants must have a vertebral level site of interest from C1 to S2
• Signed informed consent
• Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
• Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
• ECOG ≤ 2

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Brainlab AG: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amol Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amol Ghia, MD

CONTACT

(832) 628-7357; ajghia@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)