Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.
Robert J Amdur, MD
University of Florida- Radiation Oncology
United States: Institutional Review Board
IRB # 404-2005
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