Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord
N/A
N/A
Both
Spinal Tumors
Trial Information
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.
Inclusion Criteria:
- Informed consent to participate in this protocol
- Patient of all ages are eligible
- All tumor types are eligible
- Patients with prior spine radiotherapy and/or surgery to the involved area are
eligible
- The tumor target must be visible on MRI or CT scan
- Stereotactic Body Radiation Therapy (SBRT) on this protocol may produce a better
outcome than conventional radiotherapy
Exclusion Criteria:
- Patients who are likely to have a satisfactory outcome with surgical resection,
embolization, or radiofrequency ablation without the addition of radiotherapy
- Tumor size, shape, or location is such that it is not reasonable to think the patient
may benefit from SBRT as given in this protocol
- The full extent of the tumor cannot be visualized on MRI or CT scan
- Delaying radiotherapy for the time that it takes to start SBRT may compromise outcome
compared to starting conventional radiotherapy immediately
- The patient cannot be positioned reproducibly due to pain or other factors
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Description:
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.
Outcome Time Frame:
2 yrs
Safety Issue:
Yes
Principal Investigator
Robert J Amdur, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida- Radiation Oncology
Authority:
United States: Institutional Review Board
Study ID:
IRB # 404-2005
NCT ID:
NCT00631670
Start Date:
October 2005
Completion Date:
November 2008
Related Keywords:
- Spinal Tumors
- Spinal Cord Neoplasms
- Spinal Neoplasms
Name | Location |
|---|---|
| University of Florida | Gainesville, Florida 32610-0277 |
