Expired Study
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Gainesville, Florida 32610


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

IRB # 404-2005


NCT ID:

NCT00631670


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert J Amdur, MD
Principal Investigator
University of Florida- Radiation Oncology

Study Dates

Start Date:October 2005
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:February 1, 2012
First Received Date:February 29, 2008
First Results Date:November 28, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall One Year Survival
Time Frame:One year
Safety Issues:False
Description:Number of patients alive at one year after treatment
Outcome Type:Secondary Outcome
Measure:Pain Relief
Time Frame:12 weeks
Safety Issues:True
Description:Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than
Outcome Type:Secondary Outcome
Measure:Neurologic Function
Time Frame:2 years
Safety Issues:False
Description:Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit,
Outcome Type:Secondary Outcome
Measure:Local Control
Time Frame:1 year
Safety Issues:False
Description:Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Outcome Type:Primary Outcome
Measure:Toxicity
Time Frame:2 yrs
Safety Issues:True
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 inform

Study Interventions

Intervention Type:Radiation
Name:Stereotactic Body Radiation Therapy
Description:15 Gy in one treatment
Arm Name:Single Treatment Group
Intervention Type:Radiation
Name:Stereotactic Body Radiation Therapy
Description:Dose: 70 Gy at 2.8 Gy/treatment
Arm Name:25 Treatments Group

Study Arms

Study Arm Type:Experimental
Arm Name:25 Treatments Group
Description:25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Study Arm Type:Experimental
Arm Name:Single Treatment Group
Description:15 Gy dose in one stereotactic body radiation treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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