Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05617716
Collaborator
(none)
240
1
3
48
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Conventional external beam radiation therapy dose (EBRT)
  • Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose
  • Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard dose SBRT

Participants will undergo standard dose Stereotactic Body Radiation Therapy

Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose
Participants will undergo 24 Gray in 2 fractions of SBRT

Experimental: High dose SBRT

Participants will undergo high dose Stereotactic Body Radiation Therapy

Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose
Participants will undergo 19 Gray in 1 fraction of SBRT

Experimental: Conventional EBRT

Participants will undergo External Beam Radiation Therapy

Radiation: Conventional external beam radiation therapy dose (EBRT)
Participants will undergo 8 Gray in 1 fraction of EBRT

Outcome Measures

Primary Outcome Measures

  1. Pain freedom based on BPI score difference [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.

Secondary Outcome Measures

  1. Pain freedom based on BPI score difference [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.

  2. Local Control [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

  3. Vertebral compression fracture rate [6 months]

    6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months

  4. Survival [6 months]

    Overall participant survival

  5. Vertebral compression fracture rate [12 months]

    12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months

  6. Demographic disparities [3 months]

    Demographic disparities (by race, ethnicity, sex, insurance status) following spine SBRT/EBRT access and outcomes at 3 months

  7. Demographic disparities [6 months]

    Demographic disparities (by race, ethnicity, sex, insurance status) following spine SBRT/EBRT access and outcomes at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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 have no systemic chemotherapy at least 1 week before or after SBRT

  • Participant must have no non-cytotoxic systemic therapy (excluding endocrine therapy delivered within 24 hours before or after completion of SBRT)

  • 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:
  • Prior treatment toxicities resolved to < Grade 5 according to NCI CTCAE Version 4.0 (list exceptions, e.g. alopecia, neuropathy, etc)

  • 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 per ds-GPA

  • 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

  • Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Shearwood McClelland III, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT05617716
Other Study ID Numbers:
  • CASE4322
First Posted:
Nov 15, 2022
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Case Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023