- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617716
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
October 3, 2023 updated by: Case Comprehensive Cancer Center
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine.
The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT).
EBRT delivers tightly targeted radiation beams from outside the body.
SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets.
This study will include standard dose SBRT and higher dose SBRT.
Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Study Overview
Status
Recruiting
Detailed Description
Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy.
Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control.
The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results.
Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT.
The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates.
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shearwood McClelland III, MD
- Phone Number: 1-800-641-2422
- Email: CTUReferral@UHhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
-
Contact:
- Shearwood McClelland, MD
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
- Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.
- Age >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.
- Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
- Participant must have a worst pain score < 2 of 10 according to the Brief Pain Inventory
- Participant must have no intention of changing pain medications on the first day of SBRT
- Participant must have a Spinal Instability score (SINS) ≤ 12
- Participant must be a spine SBRT candidate per Radiation Oncology
- Participant must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Participant receiving any other investigational agents.
- Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
- Participant is unable to receive MRI of the spine
- Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
- Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
- Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
- Participant is not an SBRT candidate per radiation oncology discretion
- Participant has a known primary and has an estimated median survival≤ 3 months
- Participant has an unknown primary
- Participant has a Brief Pain Inventory score > 2
- Participant has received previous radiation therapy involving the intended SBRT treatment field
- Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
- Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard dose SBRT
Participants will undergo standard dose Stereotactic Body Radiation Therapy
|
Participants will undergo 24 Gray in 2 fractions of SBRT
|
Experimental: High dose SBRT
Participants will undergo high dose Stereotactic Body Radiation Therapy
|
Participants will undergo 19 Gray in 1 fraction of SBRT
|
Experimental: Conventional EBRT
Participants will undergo External Beam Radiation Therapy
|
Participants will undergo 8 Gray in 1 fraction of EBRT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain freedom based on BPI score difference
Time Frame: 3 months
|
Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10.
The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI.
Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Control
Time Frame: 6 months
|
6-month local control, defined as an actuarial 6-month rate of any new, recurrent or progressing (as defined by SPINOcriteria) tumor within the planning target volume on any post-treatment MRI by 6 months.
Follow-up MRIs will be fused with the planning scan for this assessment
|
6 months
|
Vertebral compression fracture rate
Time Frame: 6 months
|
6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months
|
6 months
|
Survival
Time Frame: 6 months
|
Overall participant survival
|
6 months
|
Vertebral compression fracture rate
Time Frame: 12 months
|
12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months
|
12 months
|
Pain freedom based on BPI score difference
Time Frame: 6 months
|
Freedom from pain at 6 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10.
The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI.
Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
|
6 months
|
Demographic disparities
Time Frame: 3 months
|
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months
|
3 months
|
Demographic disparities
Time Frame: 6 months
|
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shearwood McClelland III, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 8, 2022
First Submitted That Met QC Criteria
November 8, 2022
First Posted (Actual)
November 15, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE4322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD sharing includes individual participant data that underlie or influence the results observed in this study.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Investigators who provide a methodologically sound proposal for use of requested data
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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