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A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy

NCT01624220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-12

Study results available
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Summary

The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment.

The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.

Conditions

  • Spinal Tumor

Interventions

RADIATION

Spinal SBRT (Standard Dose)

Group 1 and 2: Standard doses of radiation therapy to the normal esophagus while treating the tumor. Up to 2 groups of 10 participants enrolled.

RADIATION

Spinal SBRT (Higher Dose)

Group 3 and 4: Higher dose of radiation to esophagus than group before it, if no intolerable side effects were seen. 2 groups of 10 participants enrolled in the second part of study. Only participants who will receive a single spinal SBRT treatment are eligible for second part of study.

PROCEDURE

Gold Seed Implantation

4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.

BEHAVIORAL

Questionnaires

Completion of questionnaire before radiation treatment starts, and 1 time a week for the next 4 weeks. It should take about 10 minutes to complete.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amol J. Ghia, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-03
Primary Completion
2023-04-14
Completion
2023-04-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624220 on ClinicalTrials.gov