Spine Stereotactic Radiosurgery for Spinal Cancer
Trial Summary
What is the purpose of this trial?
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Spine Stereotactic Radiosurgery for Spinal Cancer?
Research shows that stereotactic body radiotherapy (SBRT) is highly effective for treating spinal metastases, with improved pain relief and local control compared to traditional methods. A specific regimen of 24 Gy in 2 fractions has strong evidence for balancing effectiveness and minimizing side effects.12345
Is Spine Stereotactic Radiosurgery (SRS) safe for humans?
Spine Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are generally considered safe, but they do carry some risks. Studies have shown that while these treatments can effectively target spinal tumors, they may increase the risk of vertebral body fractures (breaks in the bones of the spine).34567
How is Spine Stereotactic Radiosurgery (SRS) different from other treatments for spinal cancer?
Spine Stereotactic Radiosurgery (SRS) is unique because it delivers high-dose radiation precisely to spinal tumors in one or two sessions, minimizing damage to surrounding healthy tissue. This advanced technique is particularly beneficial for treating tumors near the spinal cord, where conventional radiation might not be feasible due to the risk of damaging the spinal cord.12589
Research Team
Samuel T. Chao, MD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for individuals with cancer that has spread to their spine, affecting up to three separate sites without causing spinal cord compression. Participants must be in good physical condition (KPS โฅ 70), able to undergo MRI scans, and not pregnant. Those who've had prior radiation at the index site may join, but not if they've had specific spine treatments or have certain types of cancer like lymphoma.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo spine stereotactic radiosurgery (sSRS) in either one or two sessions depending on the assigned group
Follow-up
Participants are monitored for vertebral compression fractures, quality of life, local control, pain control, and toxicity
Treatment Details
Interventions
- Spine SRS in 1 fraction
- Spine SRS in 2 fraction
Spine SRS in 1 fraction is already approved in United States, European Union, Canada, Japan for the following indications:
- Vertebral metastases
- Spinal tumors
- Pain relief
- Neurological symptoms
- Vertebral metastases
- Spinal tumors
- Pain relief
- Neurological symptoms
- Vertebral metastases
- Spinal tumors
- Pain relief
- Neurological symptoms
- Vertebral metastases
- Spinal tumors
- Pain relief
- Neurological symptoms
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor