RecruitingPhase 2

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

United States60 participantsStarted 2024-11-11

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06204315

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Amol Ghia, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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