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

Primary Purpose

Spinal Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Tumors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Treatment Group

25 Treatments Group

Arm Description

15 Gy dose in one stereotactic body radiation treatment

25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment

Outcomes

Primary Outcome Measures

Toxicity
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.

Secondary Outcome Measures

Local Control
Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Neurologic Function
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, better, worse, or unchanged as noted below.
Pain Relief
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 that reported at baseline.
Overall One Year Survival
Number of patients alive at one year after treatment

Full Information

First Posted
February 29, 2008
Last Updated
February 1, 2012
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00631670
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Treatment Group
Arm Type
Experimental
Arm Description
15 Gy dose in one stereotactic body radiation treatment
Arm Title
25 Treatments Group
Arm Type
Experimental
Arm Description
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
15 Gy in one treatment
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Dose: 70 Gy at 2.8 Gy/treatment
Primary Outcome Measure Information:
Title
Toxicity
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.
Time Frame
2 yrs
Secondary Outcome Measure Information:
Title
Local Control
Description
Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Time Frame
1 year
Title
Neurologic Function
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, better, worse, or unchanged as noted below.
Time Frame
2 years
Title
Pain Relief
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 that reported at baseline.
Time Frame
12 weeks
Title
Overall One Year Survival
Description
Number of patients alive at one year after treatment
Time Frame
One year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Amdur, MD
Organizational Affiliation
University of Florida- Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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

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