Spine Radiosurgery for Spinal Cancer Spread
Recruiting in Palo Alto (17 mi)
Overseen byErqi Pollom, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Stanford University
Disqualifiers: Pediatric, Pregnant, Myeloma, Lymphoma, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.
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 Multi-fraction spine SRS, Fractionated Stereotactic Radiosurgery, Multi-fraction SRS, Stereotactic Body Radiation Therapy (SBRT), Single-fraction spine SRS, Stereotactic Body Radiation Therapy (SBRT), Stereotactic Ablative Radiotherapy (SABR), CyberKnife, Gamma Knife for spinal cancer spread?
Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective for treating spinal metastases, improving pain relief and local control compared to traditional radiation methods. Studies indicate that specific dosing schedules, like 24 Gy in 2 fractions, offer a good balance between effectiveness and minimizing side effects.
12345Is spine radiosurgery safe for treating spinal cancer spread?
Spine radiosurgery, including techniques like SRS and SBRT, is generally considered safe for treating spinal tumors, with a low risk of complications such as myelopathy (spinal cord damage) occurring in about 0.4% of patients. However, there is an increased risk of vertebral body fractures compared to traditional radiation therapy.
26789How is the treatment for spinal cancer spread using spine radiosurgery different from other treatments?
This treatment, known as Stereotactic Body Radiation Therapy (SBRT), is unique because it delivers high doses of radiation precisely to spinal tumors in fewer sessions, which can improve pain relief and control the cancer better than traditional radiation therapy. It is particularly beneficial for patients who cannot undergo surgery or have already received radiation, as it minimizes damage to surrounding healthy tissue.
123410Eligibility Criteria
This trial is for individuals with cancer that has spread to the spine. Specific details about who can join are not provided, but typically participants would need a confirmed diagnosis and may have certain health requirements.Inclusion Criteria
Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document
I am 18 or older with a confirmed diagnosis of metastatic cancer.
I agree to use effective birth control during the study.
+5 more
Exclusion Criteria
I have had or will have radiation therapy in the same area being studied.
I am not pregnant, nursing, or under 18.
I cannot have an MRI or CT scan, but I can have a CT if I have a pacemaker.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive spine Stereotactic Radiosurgery (SRS) with either 22 Gy in 1 fraction or 28 Gy in 2 fractions
1-2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain, quality of life, and tumor control
2 years
1, 3, 6, 12, 18, and 24 months following SRS
Participant Groups
The study is testing two different radiation therapy schedules for treating spinal tumors: one single high-dose treatment versus two slightly lower doses on separate days. Patients will be randomly assigned to one of these treatments.
2Treatment groups
Experimental Treatment
Group I: Single-fraction spine SRSExperimental Treatment1 Intervention
Single-fraction spine SRS (22 Gy x 1)
Group II: Multi-fraction spine SRSExperimental Treatment1 Intervention
Multi-fraction spine SRS (14 Gy x 2)
Multi-fraction spine SRS is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Stereotactic Radiosurgery for:
- Spinal metastases
- Vertebral tumors
- Bone metastases
🇪🇺 Approved in European Union as Stereotactic Radiosurgery for:
- Spinal metastases
- Vertebral tumors
- Bone metastases
🇨🇦 Approved in Canada as Stereotactic Radiosurgery for:
- Spinal metastases
- Vertebral tumors
- Bone metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford University School of MedicinePalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
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 body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]Stereotactic body radiotherapy (SBRT) has proven to be a highly effective treatment for selected patients with spinal metastases. Randomized evidence shows improvements in complete pain response rates and local control with lower retreatment rates favoring SBRT, compared to conventional external beam radiotherapy (cEBRT). While there are several reported dose-fractionation schemes for spine SBRT, 24 Gy in 2 fractions has emerged with Level 1 evidence providing an excellent balance between minimizing treatment toxicity while respecting patient convenience and financial strain.
Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]Stereotactic body radiotherapy (SBRT) is used to deliver ablative dose of radiation to spinal metastases.
Clinical outcomes of multileaf collimator-based CyberKnife for spine stereotactic body radiation therapy. [2018]Stereotactic body radiotherapy (SBRT) for spinal metastases is becoming a prevalent therapeutic option. We aimed to evaluate the clinical feasibility and outcomes of the recently developed multileaf collimator (MLC)-based CyberKnife (CK-M) for spine SBRT.
Dose-Escalated 2-Fraction Spine Stereotactic Body Radiation Therapy: 28 Gy Versus 24 Gy in 2 Daily Fractions. [2023]Stereotactic body radiation therapy (SBRT) for spine metastases improves pain response rates compared with conventional external beam radiation therapy; however, the optimal fractionation schedule is unclear. We report local control and toxicity outcomes after dose-escalated 2-fraction spine SBRT.
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.
[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]Cyberknife (Accuray Inc. Sunnyvale, USA) stereotactic body radiation therapy (SBRT) involves the delivery of a small number of large doses of radiation to a target volume using continuously evolving advanced technology. It has emerged as a novel treatment modality for cancer and modified some concepts of cancer treatment. It is indicated in early-stage primary cancer, sometimes as an alternative to surgery. It is also indicated for patients with oligometastatic disease who have relatively long survival with the aim to optimize disease control with a good quality of life. Although there remain some uncertainties regarding the radiobiology of hypofractionation, local control and tolerance have been promising. Indications are increasing under strict quality assurance programs worldwide and prospective clinical evaluation.
Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases. [2023]Stereotactic body radiation therapy (SBRT) offers efficient, noninvasive treatment of spinal neoplasms. Single-fraction (SF) high-dose SBRT has a relatively narrow therapeutic window, while hypofractionated delivery of SBRT may have an improved safety profile with similar efficacy. Because the optimal approach of delivery is unknown, the authors examined whether hypofractionated SBRT improves pain and/or functional outcomes and results in better tumor control compared with SF-SBRT.
Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. [2023]Stereotactic body radiation therapy (SBRT) is utilized to deliver highly conformal, dose-escalated radiation to a target while sparing surrounding normal structures. Spinal SBRT can allow for durable local control and palliation of disease while minimizing the risk of damage to the spinal cord; however, spinal SBRT has been associated with an increased risk of vertebral body fractures. This study sought to compare the fracture rates between SBRT and conventionally fractionated external-beam radiation therapy (EBRT) in patients with metastatic spine tumors.
Stereotactic body radiotherapy reirradiation for recurrent epidural spinal metastases. [2011]When patients show progression after conventional fractionated radiation for spine metastasis, further radiation and surgery may not be options. Stereotactic body radiotherapy (SBRT) has been successfully used in treatment of the spine and may be applicable in these cases. We report the use of SBRT for 60 consecutive patients (81 lesions) who had radiological progressive spine metastasis with epidural involvement after previous radiation for spine metastasis.