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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Demographic disparities
Local Control
Pain freedom based on BPI score difference
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
469 Previous Clinical Trials
33,230 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The origin of my cancer is unknown.I am not considered a candidate for SBRT according to my radiation oncologist.I have nerve issues due to cancer in my spine.My spine treatment involves more than 3 backbones in a row.I do not have any severe illnesses that could interfere with the study.I have had spine surgery in the area targeted for radiation, but not just a biopsy.I am over 18 years old.My worst pain level is less than 2 on a scale of 0 to 10.I am not pregnant or nursing, as radiation therapy could be harmful.I have had radiation therapy in the same area where SBRT is planned.I've had targeted radiation therapy that overlaps with my current treatment area.My doctor estimates I have 3 months or less to live.I am a candidate for spine radiation therapy as per my oncologist.I can understand and am willing to sign the consent form.I do not plan to change my pain medication on the day I start SBRT.My spine is unstable due to cancer, as measured by a specific score.My cancer diagnosis and spinal metastasis are confirmed by tests.I have not had any previous treatments, including radiation, for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional EBRT
- Group 2: High dose SBRT
- Group 3: Standard dose SBRT
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.