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Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Primary Purpose

Metastatic Neoplasm to the Spine, Metastatic Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Conventional external beam radiation therapy dose (EBRT)
Spine radiosurgery/stereotactic body radiation therapy standard dose
Spine radiosurgery/stereotactic body radiation therapy high dose
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Neoplasm to the Spine focused on measuring Radiosurgery, External Beam Radiation Therapy, Stereotactic Body Radiation Therapy, Spine Stereotactic Radiosurgery, SPORTSMEN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard dose SBRT

High dose SBRT

Conventional EBRT

Arm Description

Participants will undergo standard dose Stereotactic Body Radiation Therapy

Participants will undergo high dose Stereotactic Body Radiation Therapy

Participants will undergo External Beam Radiation Therapy

Outcomes

Primary Outcome Measures

Pain freedom based on BPI score difference
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.

Secondary Outcome Measures

Pain freedom based on BPI score difference
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.
Local Control
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
Vertebral compression fracture rate
6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months
Survival
Overall participant survival
Vertebral compression fracture rate
12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months
Demographic disparities
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months
Demographic disparities
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months

Full Information

First Posted
November 8, 2022
Last Updated
October 3, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05617716
Brief Title
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Official Title
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Neoplasm to the Spine, Metastatic Neoplasm
Keywords
Radiosurgery, External Beam Radiation Therapy, Stereotactic Body Radiation Therapy, Spine Stereotactic Radiosurgery, SPORTSMEN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard dose SBRT
Arm Type
Experimental
Arm Description
Participants will undergo standard dose Stereotactic Body Radiation Therapy
Arm Title
High dose SBRT
Arm Type
Experimental
Arm Description
Participants will undergo high dose Stereotactic Body Radiation Therapy
Arm Title
Conventional EBRT
Arm Type
Experimental
Arm Description
Participants will undergo External Beam Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Conventional external beam radiation therapy dose (EBRT)
Intervention Description
Participants will undergo 8 Gray in 1 fraction of EBRT
Intervention Type
Radiation
Intervention Name(s)
Spine radiosurgery/stereotactic body radiation therapy standard dose
Intervention Description
Participants will undergo 24 Gray in 2 fractions of SBRT
Intervention Type
Radiation
Intervention Name(s)
Spine radiosurgery/stereotactic body radiation therapy high dose
Intervention Description
Participants will undergo 19 Gray in 1 fraction of SBRT
Primary Outcome Measure Information:
Title
Pain freedom based on BPI score difference
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain freedom based on BPI score difference
Description
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.
Time Frame
6 months
Title
Local Control
Description
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
Time Frame
6 months
Title
Vertebral compression fracture rate
Description
6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months
Time Frame
6 months
Title
Survival
Description
Overall participant survival
Time Frame
6 months
Title
Vertebral compression fracture rate
Description
12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months
Time Frame
12 months
Title
Demographic disparities
Description
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months
Time Frame
3 months
Title
Demographic disparities
Description
Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shearwood McClelland III, MD
Phone
1-800-641-2422
Email
CTUReferral@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shearwood McClelland III, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shearwood McClelland, MD
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

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