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Radiation Therapy

Radiation Therapy for Spinal Cancer

Phase 2
Recruiting
Led By Shearwood McClelland III, 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
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.
Participant must have a worst pain score < 2 of 10 according to the Brief Pain Inventory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial compares 3 types of radiation therapy for cancer that has spread to the spine. EBRT and SBRT deliver radiation to the body from outside or target small areas respectively. Patients are randomly assigned to one of the 3 radiation therapies.

Who is the study for?
Adults over 18 with cancer that has spread to the spine, expected to live at least 3 more months, and experiencing moderate pain. They must not have had previous treatments for these spinal tumors or be planning to change pain meds during the trial. Pregnant women, those with severe illnesses or instability in their spines are excluded.Check my eligibility
What is being tested?
The study compares three radiation therapies for patients with metastatic spine cancer: high-dose SBRT (precise high-dose radiation), standard-dose SBRT, and conventional EBRT (targeted beams from outside). Participants will be randomly assigned one of these treatments.See study design
What are the potential side effects?
Radiation therapy side effects can include fatigue, skin reactions at the treatment site, mild swelling or stiffness in nearby muscles or joints, nausea, and rarely more serious complications like damage to surrounding organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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My worst pain level is less than 2 on a scale of 0 to 10.
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I do not plan to change my pain medication on the day I start SBRT.
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My cancer diagnosis and spinal metastasis are confirmed by tests.
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I am a candidate for spine radiation therapy as per my oncologist.
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I have not had any previous treatments, including radiation, for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Demographic disparities
Local Control
Pain freedom based on BPI score difference
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard dose SBRTExperimental Treatment1 Intervention
Participants will undergo standard dose Stereotactic Body Radiation Therapy
Group II: High dose SBRTExperimental Treatment1 Intervention
Participants will undergo high dose Stereotactic Body Radiation Therapy
Group III: Conventional EBRTExperimental Treatment1 Intervention
Participants will undergo External Beam Radiation Therapy

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,114 Total Patients Enrolled
1 Trials studying Spinal Tumors
8 Patients Enrolled for Spinal Tumors
Shearwood McClelland III, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Conventional External Beam Radiation Therapy Dose (EBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05617716 — Phase 2
Spinal Tumors Research Study Groups: Conventional EBRT, High dose SBRT, Standard dose SBRT
Spinal Tumors Clinical Trial 2023: Conventional External Beam Radiation Therapy Dose (EBRT) Highlights & Side Effects. Trial Name: NCT05617716 — Phase 2
Conventional External Beam Radiation Therapy Dose (EBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617716 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to participants in this clinical experiment presently?

"Clinicaltrials.gov records indicate that this study is no longer accepting participants, as the trial's first posting was on January 1st 2023 and its most recent amendments were made on November 8th 2022. However, 2928 other clinical trials are currently enrolling patients."

Answered by AI

How can patients be assured of safety when undergoing High dose SBRT?

"Although efficacy data is yet to be published, the High dose SBRT has been assessed as a 2 on our team's scale of 1-3 for safety due to Phase 2 trial results."

Answered by AI
~158 spots leftby Jun 2026