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Radiation Therapy
Spine Stereotactic Radiosurgery for Spinal Cancer
Phase 2
Recruiting
Led By Samuel Chao, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
Karnofsky Performance Status (KPS) ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)
Awards & highlights
Study Summary
This trial will compare two different approaches to spine SRS. One group will receive 1 treatment, and the other group will receive 2 treatments given 1 week apart.
Who is the study for?
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 ≥ 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.Check my eligibility
What is being tested?
The study compares single-session versus two-session Spine Stereotactic Radiosurgery (sSRS) for treating vertebral metastases. It aims to determine which method better prevents vertebral compression fractures after delivering high-dose x-ray treatments focused on the affected areas of the spine.See study design
What are the potential side effects?
A potential side effect of sSRS is developing vertebral compression fractures; many are non-painful. Other risks typically associated with radiation therapy may include skin irritation near the treatment area and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to my spine from the neck down to the lower back.
Select...
I am able to care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS
Secondary outcome measures
Local control (LC) as defined as absence of local progression of disease In the event of disease progression, all cases will be reviewed at the multi-disciplinary spine tumor board for a consensus recommendation
Pain control (PC) as assessed by the Brief Pain Inventory (BPI)
Quality of life (QOL) assessed by EORTC QLQ-C30 (with BM22)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 - Single fractionExperimental Treatment6 Interventions
sSRS 18 Gy in 1 fraction
Group II: Arm 2 - Two fractionActive Control6 Interventions
sSRS 24 Gy in 2 fractions
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,780 Total Patients Enrolled
Samuel Chao, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
2 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an ongoing connective tissue disease that is currently active.My cancer has spread to more than 5 levels of my spine.I have a spinal cord compression that needs urgent care.I have a spinal bone problem causing nerve issues.I am able to attend all required follow-up visits and imaging.My overall health status fits within a specific range and my cancer is either controlled or not, depending on other health factors.I have had spine surgery at the site where targeted radiation is planned.I have a mass near my spine larger than 5 cm.I've had a recent neurological exam showing no rapid decline, with minor to moderate issues acceptable.My spine is not stable.I am unable to take part in study activities due to physical or mental health issues.I have spinal cord compression.I have a spinal condition but no pressure on my spinal cord.My cancer has spread to the area near my spine but is less than 5 cm.My condition affects the top of my spine or the bottom near my tailbone.I cannot undergo a specific type of radiation therapy.My cancer has spread to my spine from the neck down to the lower back.My cancer has spread to my spine in a limited way.I have small cancer spread in my bones but it's less than 20% of any bone and not where I'm getting radiation.I have more than one type of cancer.My neurological condition is worsening quickly.My cancer, which may include sarcoma, melanoma, or renal cell carcinoma, is resistant to radiation.I have had radiation therapy at the cancer site before.I am able to care for myself but may not be able to do active work.I have had stereotactic radiosurgery on my spine before.I have a blood cancer, such as lymphoma or myeloma.My cancer originated in my spine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Single fraction
- Group 2: Arm 2 - Two fraction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Diagnostic MRI obtained regulatory endorsement from the FDA?
"Diagnostic MRI has been assigned a safety rating of 2, as this is still an experimental phase and there are only limited findings that can back up the therapy's efficacy."
Answered by AI
Is registration still available for this clinical experiment?
"Affirmative. The online clinical trials database confirms that this research project, which was first posted on February 7th 2020, is still recruiting participants - 130 in total across a single site."
Answered by AI
What is the size of the cohort participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov lends credence to this trial's ongoing recruitment, which first began on February 7th 2020 and was recently updated on May 24th 2022. 130 participants are being sought from a single site."
Answered by AI
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