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

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

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 Overview

• Status: Completed
• Conditions: Spinal Tumors
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Treatment Group; 15 Gy dose in one stereotactic body radiation treatment	Radiation: Stereotactic Body Radiation Therapy; 15 Gy in one treatment; Radiation: Stereotactic Body Radiation Therapy; Dose: 70 Gy at 2.8 Gy/treatment
EXPERIMENTAL: 25 Treatments Group; 25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment	Radiation: Stereotactic Body Radiation Therapy; 15 Gy in one treatment; Radiation: Stereotactic Body Radiation Therapy; Dose: 70 Gy at 2.8 Gy/treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 yrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control	Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery	1 year
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.	2 years
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.	12 weeks
Overall One Year Survival	Number of patients alive at one year after treatment	One year

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (ESTIMATE): March 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Bone Neoplasms; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: IRB # 404-2005