Cement Augmentation for Cancer with Spinal Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, patients undergoing bisphosphonate therapy are allowed to continue.
Is stereotactic radiosurgery safe for treating spinal metastases?
How is the treatment Stereotactic Radiosurgery (SRS) unique for spinal metastases?
Stereotactic Radiosurgery (SRS) is unique because it is a noninvasive treatment that delivers precise, high-dose radiation to spinal metastases, improving pain relief and local control with fewer retreatments compared to conventional radiotherapy. It offers a balance between effectiveness and minimizing side effects, often using advanced technology like CyberKnife or Gamma Knife.12678
What data supports the effectiveness of the treatment for spinal metastases?
Research shows that stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are effective treatments for spinal metastases, improving pain relief and local tumor control compared to traditional methods. These treatments are noninvasive and have been shown to reduce the need for retreatment, offering a good balance between effectiveness and minimizing side effects.126910
Who Is on the Research Team?
Amol J. Ghia
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with solid tumors that have spread to the spine, can lie flat, and are at high risk of spinal fractures post-radiosurgery. They should be relatively active (able to care for themselves), expected to live more than 3 months, and agree to use contraception. Those who've had prior spine surgery or radiotherapy at the same spot, severe vertebral damage, or certain cancers like lymphoma aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo stereotactic spinal radiosurgery and may receive vertebral body cement augmentation
Follow-up
Participants are monitored for safety, effectiveness, and quality of life every 3 months
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Radiosurgery
- Vertebral Body Cement Augmentation
Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator