← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

I can lie flat on my back.

Select...

The part of my spine needing treatment is between my upper back and lower back.

Select...

I have had treatment on up to 3 connected or separate spine bones.

Select...

I have a solid tumor cancer that has spread to my spine.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases

Secondary outcome measures

Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases

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

~3330

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,266 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

Frequently Asked Questions

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

How many participants is this clinical trial enrolling?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical study, which was first announced on January 18th 2017, is currently recruiting volunteers. Approximately 80 individuals need to be recruiter from 1 location."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned any Questionnaires?

"Our team at Power has rated the safety of Questionnaires a 2 since this is Phase 2, implying that there have been some studies to back up its security but no trials demonstrating efficacy."

Answered by AI

Are there still opportunities to participate in this clinical experiment?

"Affirmative, according to the details posted on clinicaltrials.gov, this trial is still recruiting participants. The study was initially released on January 18th 2017 and has been updated as recently as September 22nd 2022. At present 80 patients need to be enrolled at 1 site in order for the trial to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases

2017. "Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03028337.

All > Bone Metastases