Radiation for Spine Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stony Brook University
Disqualifiers: Unstable spine, Previous surgery, Radiosensitive tumors
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
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 SBRT for spine cancer?
Research shows that SBRT (Stereotactic Body Radiation Therapy) is highly effective for treating spinal metastases, improving pain relief and controlling cancer spread better than traditional radiation methods, with fewer repeat treatments needed.
12345Is stereotactic body radiation therapy (SBRT) safe for treating spine cancer?
Research shows that stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is generally safe for treating spinal metastases, with studies indicating it balances minimizing treatment side effects while being effective.
15678How is the treatment SBRT different from other treatments for spine cancer?
SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to the tumor in the spine, minimizing damage to surrounding healthy tissue. This precision allows it to be used effectively for spine metastases, even in areas close to the spinal cord, with a low risk of side effects like myelopathy (spinal cord damage).
910111213Eligibility Criteria
This trial is for patients with solid tumor cancers, excluding brain origin, that have spread to the spine. Participants must have a maximum of 3 affected spinal segments and maintain basic neurological function or minor deficits. They should be evaluated by specialists and have an ECOG Performance Status score between 0-3.Inclusion Criteria
My muscle strength is mostly normal, at least 4 out of 5, with or without medication.
I have been evaluated by a specialist in cancer radiation and spine surgery.
My spine issue affects up to 3 connected vertebrae.
+3 more
Exclusion Criteria
I have had surgery or radiation for cancer in my spine.
An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
My cancer type is known to respond well to radiation therapy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive stereotactic body radiation therapy (SBRT) to the spine
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Assessments at 1, 3, and 6 months
Participant Groups
The study tests if stereotactic body radiation therapy (SBRT) can effectively treat aggressive spinal metastases in cancer patients without needing major surgery.
1Treatment groups
Experimental Treatment
Group I: SBRT to the spineExperimental Treatment1 Intervention
SBRT is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as SBRT for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
🇪🇺 Approved in European Union as SBRT for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Bone metastases
🇨🇦 Approved in Canada as SBRT for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
🇯🇵 Approved in Japan as SBRT for:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stony Brook University HospitalStony Brook, NY
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Who Is Running the Clinical Trial?
Stony Brook UniversityLead Sponsor
The University of Texas Health Science Center at San AntonioCollaborator
References
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.
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.
Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. [2022]The authors report data concerning the safety, effectiveness, and patterns of failure obtained in a Phase I/II study of stereotactic body radiotherapy (SBRT) for spinal metastatic tumors.
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 ablative radiation therapy for spinal metastases: experience at a single Brazilian institution. [2023]This study aims to assess the clinical outcomes of patients with spine metastases who underwent stereotactic ablative radiation therapy (SABR) as part of their treatment. SABR has arisen as a contemporary treatment option for spinal metastasis patients with good prognoses.
Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. [2019]To evaluate the outcome and toxicities of stereotactic ablative radiotherapy (SABR) for skeletal metastasis in a tertiary cancer center.
Stereotactic body radiation therapy in spinal metastases. [2022]Based on reports of safety and efficacy, stereotactic body radiotherapy (SBRT) for treatment of malignant spinal tumors was initiated at our institution. We report prospective results of this population at Mayo Clinic.
Knowledge-Based Planning for Identifying High-Risk Stereotactic Ablative Radiation Therapy Treatment Plans for Lung Tumors Larger Than 5 cm. [2019]Stereotactic ablative body radiation therapy (SABR) for lung tumors ≥5 cm can be associated with more toxicity than that for smaller tumors. We investigated the relationship between dosimetry and toxicity and used a knowledge-based planning solution to retrospectively perform individualized treatment plan quality assurance (QA) with the aim of identifying where planning could have been improved.
Long-term outcomes of spinal SBRT. Is it important to select the treatment time? [2022]SBRT (stereotactic body radiation therapy) is widely used as a curative treatment in tumoral lesions and has become a fundamental tool for the treatment of spine metastasis. In this study, we present survival and toxicity outcomes of spine SBRT after a 2-year follow-up.
Dosimetric analysis of varying cord planning organ at risk volume in spine stereotactic body radiation therapy. [2020]Spine stereotactic body radiation therapy (SBRT) is becoming widely accepted as first-line treatment of oligometastatic spine disease as well as in the postoperative setting. The reported incidence of myelopathy is very low and guidelines vary widely on the maximum tolerable dose of the spinal cord and thecal sac.
Comparison of setup accuracy and efficiency between the Klarity system and BodyFIX system for spine stereotactic body radiation therapy. [2022]Spine stereotactic body radiation therapy (SBRT) uses highly conformal dose distributions and sharp dose gradients to cover targets in proximity to the spinal cord or cauda equina, which requires precise patient positioning and immobilization to deliver safe treatments.
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.
Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. [2022]Spinal stereotactic body radiation therapy (SBRT) is increasingly used to manage spinal metastases, yet the technique's effectiveness in controlling the symptom burden of spinal metastases has not been well described. We investigated the clinical benefit of SBRT for managing spinal metastases and reducing cancer-related symptoms.