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Radiation Therapy

Spinal SBRT (Standard Dose) for Spinal Tumors

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial is testing a new way to give radiation to tumors in the spine while also trying to learn if it is safe to give a little more radiation to nearby normal tissue.

Eligible Conditions
  • Spinal Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess Use of Implanted Fiducial Markers in Treatment Planning and Delivery Workflow for Frame-Based Spinal Stereotactic Body Radiation Therapy (Spinal SBRT)
Secondary outcome measures
Esophageal Tolerance to Hyperfractionation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hypofractionated RadiationExperimental Treatment3 Interventions
All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor. In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
Group II: ExacTrac Positioning SystemExperimental Treatment3 Interventions
Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal SBRT (Standard Dose)
2012
N/A
~50
Spinal SBRT (Higher Dose)
2012
N/A
~50
Questionnaires
2013
Completed Phase 2
~3330
Gold Seed Implantation
2012
N/A
~50

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,280 Total Patients Enrolled
1 Trials studying Spinal Tumors
11 Patients Enrolled for Spinal Tumors
Amol J. Ghia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
355 Total Patients Enrolled

Frequently Asked Questions

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

Are volunteers being accepted for this trial currently?

"As indicated on clinicaltrials.gov, this trial is not currently seeking participants; however, it was initially posted on June 1st 2012 and amended lastly on October 11th 2022. Fortunately, 12 alternative studies are presently searching for volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
2012. "A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01624220.
~3 spots leftby Apr 2025
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