RECRUITING

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

Conditions

Spinal Cord Metastatic Epidural Spine Stereotactic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-11

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06204315

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Amol Ghia, MD

CONTACT

(832) 628-7357

ajghia@mdanderson.org

Principal Investigator

Amol Ghia, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Amol Ghia, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord
Metastatic Epidural
Spine Stereotactic