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Radiation

Spine Radiosurgery for Cancer

Phase 2
Recruiting
Led By Amol J. Ghia, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age must be greater than or equal to 18 years
Patients must be able to lie supine
Must not have
Prior history of radiation at the site of interest resulting in a critical neural tissue dose exceeding specified limits
Patients unable to lie flat comfortably for 2 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare a single large dose of spine radiosurgery to 3 smaller doses. Researchers want to see if the single dose is better in terms of symptoms, pain, and quality-of-life.

Who is the study for?
This trial is for adults with solid tumor cancers that have spread to the spine and were previously treated with radiation. They must be able to lie flat, have a life expectancy over 6 months, and agree to use contraception. Excluded are pregnant women, those who can't undergo MRI, or had high-dose spinal radiation within 6 months.
What is being tested?
The study compares two methods of delivering spine radiosurgery for cancer that has spread to the spine: one single large dose versus three smaller doses. It aims to determine which method is more effective at managing symptoms and improving quality of life.
What are the potential side effects?
Potential side effects may include discomfort from lying still during treatment, skin reactions similar to sunburns, fatigue, nausea, and in rare cases could involve nerve damage due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can lie flat on my back.
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The part of my spine needing treatment is between my upper back and lower back.
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I have had treatment on up to 3 connected or separate spine bones.
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I have a solid tumor cancer that has spread to my spine.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had radiation at a specific site that exceeded safe levels for nerve tissue.
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I cannot lie flat comfortably for 2 hours.
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My cancer is either lymphoma or myeloma.
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I have not had radiation on the tumor site in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Secondary study objectives
Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Spine Radiosurgery - 1 DoseExperimental Treatment2 Interventions
Participants receive spine radiosurgery in a single large dose.
Group II: Spine Radiosurgery - 3 DosesActive Control2 Interventions
Participants receive spine radiosurgery over 3 smaller doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~4280

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,247 Total Patients Enrolled
Amol J. Ghia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
316 Total Patients Enrolled

Media Library

Spine Radiosurgery (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03028337 — Phase 2
Central Nervous System Cancers Research Study Groups: Spine Radiosurgery - 3 Doses, Spine Radiosurgery - 1 Dose
Central Nervous System Cancers Clinical Trial 2023: Spine Radiosurgery Highlights & Side Effects. Trial Name: NCT03028337 — Phase 2
Spine Radiosurgery (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03028337 — Phase 2
~24 spots leftby May 2028
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