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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord; Metastatic Epidural; Spine Stereotactic
• Intervention / Treatment: Radiation: Stereotactic Radiosurgery

Detailed Description

Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D).

Secondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amol Ghia, MD; Phone Number: (832) 628-7357; Email: ajghia@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
      • Contact: Amol Ghia, MD; Phone Number: 832-628-7357; Email: ajghia@mdanderson.org
      • Principal Investigator: Amol Ghia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Radiosurgery; A non-invasive, non-surgical procedure that precisely delivers radiation to cancer on the spine while avoiding surrounding, healthy tissue.	Radiation: Stereotactic Radiosurgery; Given by RTx; Other Names: CDE-SSRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Brainlab AG
• Investigators: Principal Investigator: Amol Ghia, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression
• Other Study ID Numbers: 2023-0287; NCI-2024-00049 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No