Spine Radiosurgery for Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnancy, Lymphoma, Myeloma, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
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 Radiosurgery for Cancer?
Research shows that stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are effective treatments for spinal metastases, which are cancerous growths that spread to the spine. These treatments have been shown to work well in different situations, including as a first treatment, after surgery, and even for tumors that are usually hard to treat with radiation.
12345Is spine radiosurgery safe for humans?
Spine radiosurgery, also known as stereotactic body radiotherapy (SBRT) or stereotactic radiosurgery (SRS), is generally considered safe for treating spinal tumors, with complications being rare. The risk of myelopathy (spinal cord damage) is estimated to be very low, affecting only about 0.4% of patients.
46789How is spine radiosurgery different from other treatments for spinal metastases?
Spine radiosurgery (also known as stereotactic body radiotherapy, SBRT) is unique because it delivers high-dose radiation precisely to spinal tumors, allowing for effective tumor and pain control while minimizing damage to surrounding healthy tissue. This advanced technique is particularly beneficial for treating tumors near the spinal cord, where conventional radiotherapy may not be feasible due to the risk of damaging the spinal cord.
410111213Eligibility Criteria
This trial is for adults with solid tumor cancers that have spread to the spine and were previously treated with radiation. They must be able to lie flat, have a life expectancy over 6 months, and agree to use contraception. Excluded are pregnant women, those who can't undergo MRI, or had high-dose spinal radiation within 6 months.Inclusion Criteria
I have had surgery or laser treatment before.
I am eligible regardless of my gender, race, or ethnicity.
Life expectancy must be greater than 6 months
+10 more
Exclusion Criteria
I've had radiation at a specific site that exceeded safe levels for nerve tissue.
I cannot lie flat comfortably for 2 hours.
My cancer is either lymphoma or myeloma.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiosurgery
Participants receive spine radiosurgery in either 1 large dose or 3 smaller doses
1-2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Visits at Months 3, 6, 9, 12, 18, 24, and every 6 months thereafter
Participant Groups
The study compares two methods of delivering spine radiosurgery for cancer that has spread to the spine: one single large dose versus three smaller doses. It aims to determine which method is more effective at managing symptoms and improving quality of life.
2Treatment groups
Experimental Treatment
Active Control
Group I: Spine Radiosurgery - 1 DoseExperimental Treatment2 Interventions
Participants receive spine radiosurgery in a single large dose.
Group II: Spine Radiosurgery - 3 DosesActive Control2 Interventions
Participants receive spine radiosurgery over 3 smaller doses.
Spine Radiosurgery is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Spine SBRT for:
- Vertebral metastases
- Spinal tumors
🇺🇸 Approved in United States as Spine SBRT for:
- Vertebral metastases
- Spinal tumors
- Painful vertebral metastases
🇨🇦 Approved in Canada as Spine SBRT for:
- Vertebral metastases
- Spinal tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019]The purpose of this concise update is to describe the emerging treatment of stereotactic body radiotherapy (SBRT) for spinal metastases.
International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. [2022]Spinal stereotactic radiosurgery (SRS) is increasingly used to manage spinal metastases. However, target volume definition varies considerably and no consensus target volume guidelines exist. This study proposes consensus target volume definitions using common scenarios in metastatic spine radiosurgery.
Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. [2021]To investigate the clinical outcome including efficacy and safety of stereotactic body radiotherapy (SBRT) in management of spinal metastasis.
Stereotactic body radiation for the spine: a review. [2013]Stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) for spinal metastases are emerging treatment paradigms in the multidisciplinary management of metastases located within or adjacent (paraspinal) to the vertebral bodies/spinal cord. In this review, we provide a brief overview of spine SBRT/SRS indications, technology, planning, and treatment delivery; review the current state of the literature; and discuss the radiobiology, toxicity, and limitations of SBRT/SRS for metastatic disease of the spine.
Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]Stereotactic body radiotherapy (SBRT) is an emerging treatment option for spinal metastases with demonstrated efficacy in the upfront, postoperative, and re-treatment settings, as well as for tumor histologies considered radioresistant. Uncertainty exists regarding the optimal dose and fractionation schedule, with single and multifraction regimens commonly utilized.
Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]Paraspinal stereotactic body radiotherapy (SBRT) involves risks of severe complications. We evaluated the safety of the paraspinal SBRT program in a large academic hospital by applying failure modes and effects analysis.
Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]This updated report on stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) is part of a series of consensus-based white papers previously published addressing patient safety. Since the first white papers were published, SRS and SBRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The complexity and submillimeter accuracy, and delivery of a higher dose per fraction requires an emphasis on best practices for technical, dosimetric, and quality assurance. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Stereotactic Radiosurgery for Postoperative Spine Malignancy: A Systematic Review and International Stereotactic Radiosurgery Society Practice Guidelines. [2022]To determine safety and efficacy of postoperative spine stereotactic body radiation therapy (SBRT) in the published literature, and to present practice recommendations on behalf of the International Stereotactic Radiosurgery Society.
Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. [2017]Stereotactic radiosurgery (SRS) is increasingly utilized for the treatment of primary and metastatic spinal tumors. SRS implies high dose per fraction radiation (typically >5 Gy per fraction) is delivered to an image-guided target in 1 to 5 fractions by using conformal radiation techniques. Its use is based on the radiobiological superiority of hypofractionated high dose radiation and precision of radiation delivery using real time image-guidance facilities. Spine SRS devices can be classified into two groups according to the type of treatment unit: Cyberknife (Accuray, Inc., Sunnyvale, CA, USA) and multileaf collimation (MLC) linear accelerator (LINAC) systems. The major indications for the use of SRS include primary and metastatic spine tumors. In spine metastasis, SRS was reported to be highly effective at decreasing pain, regardless of prior radiation, with an overall pain improvement rate of 85% and local control rate of approximately 90%. Improved local control could lead to more effective palliation and potentially longer survival. Some of benign spinal disease such as schwannoma, neurofibroma, meningioma, hemangioblastoma and vascular malformations were also treated. Complications associated with spinal SRS have been rarely reported, myelopathy risk is estimated to be 0.4% of treated patients. We believe that SRS is an established treatment for patients with spinal tumors, which is both safe and highly effective. The purpose of this review is to introduce principles of spinal SRS and summarize the literature regarding the usefulness of SRS for treatment of spinal neoplasms.
The role of stereotactic body radiotherapy and stereotactic radiosurgery in the re-irradiation of metastatic spinal tumors. [2014]Stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are advanced radiotherapy delivery techniques that allow for the delivery of high-dose per fraction radiation. Advances in imaging technology and intensity modulation have allowed SRS and SBRT to be used for the treatment of tumors in close proximity to the spinal cord and cauda equina, in particular spinal metastases. While the initial treatment of spinal metastases is often conventional palliative radiotherapy, treatment failure is not uncommon, and conventional re-irradiation may not be feasible due to spinal cord tolerance. SBRT and SRS have emerged as important techniques for the treatment of spinal metastases in the proximity of previously irradiated spinal cord. Here we review the current data on the use of SBRT and SRS spinal re-irradiation, and future directions for these important treatment modalities.
Spine radiosurgery for spinal metastases: indications, technique and outcome. [2014]Early diagnosis, better imaging, and advanced treatment of cancer patients extend survival and increase the incidence of symptomatic spine metastases. The treatment algorithm for spine metastases has shifted to a more aggressive approach in recent years. Spine stereotactic radiosurgery (SRS) is a relatively new tool utilizing advanced imaging systems, planning software, image-guided localization, and intensity-modulated dose delivery. Radiosurgery of spine metastases yields high rates of pain- and tumor control, and offers both the patients and the treating physicians an effective noninvasive alternative. This review presents the indications and outcomes for SRS and describes current techniques.
Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]Stereotactic body radiation therapy (SBRT) appears an effective and safe treatment modality for spinal bone metastasis, which can enhance local control and improve quality of life. Life expectation, predicted fracture risk, localization, quality, size and number of metastasis and presence or absence of nerve compression seem to be important factors in decision-making for treatment. Further studies are needed to identify subsets of patient which will most benefit from treatment.
Stereotactic body radiotherapy: a new paradigm in the management of spinal metastases. [2022]Spine stereotactic body radiotherapy is based on delivering high biologically effective doses to spinal metastases, with the intent to maximize both tumor and pain control. The purpose of this review is to outline the technical details of spine stereotactic body radiotherapy, contrast clinical outcomes to low biologically effective dose conventional palliative radiotherapy, discuss the role of surgery in the era of spine stereotactic body radiotherapy, and summarize the major serious adverse events that patients would otherwise not be at risk of with conventional radiotherapy.