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

Spinal Cord Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204315
• Other study ID #: 2023-0287
• Secondary ID: NCI-2024-00049
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: M.D. Anderson Cancer Center
• Contact: Amol Ghia, MD
• Phone: (832) 628-7357
• Email: ajghia[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord
• Spinal Cord Compression

Intervention

Radiation:
• Stereotactic Radiosurgery
Given by RTx

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Brainlab AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   MD Anderson Cancer Center