Clinical Trials Directory

Trials / Completed

CompletedNCT00631670

Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.

Detailed description

This protocol is a study of the use of Stereotactic Body Radiation Therapy (SBRT) for all types of primary or metastatic tumors near the spinal cord. The major goal of this study is to evaluate the efficacy and toxicity of a specific SBRT program in a prospective manner. The main outcome variables in this study are pain and neurologic function. A major issue in delivering SBRT is the number of treatment sessions. There are advantages and disadvantages to both single and multi treatment programs. In this protocol, patients are offered SBRT with either a single treatment or 25 treatment days. This study is not designed to compare different SBRT schedules. A single treatment program is more convenient and likely to relieve symptoms sooner than a multi-session program. A program with 25 treatments may produce better long-term results. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments.

Conditions

Interventions

TypeNameDescription
RADIATIONStereotactic Body Radiation Therapy15 Gy in one treatment
RADIATIONStereotactic Body Radiation TherapyDose: 70 Gy at 2.8 Gy/treatment

Timeline

Start date
2005-10-01
Primary completion
2008-10-01
Completion
2008-11-01
First posted
2008-03-10
Last updated
2012-02-03
Results posted
2012-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00631670. Inclusion in this directory is not an endorsement.