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

Spinal Tumors Clinical Trial

Official title:

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631670
• Other study ID #: IRB # 404-2005
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: February 1, 2012
• Start date: October 2005
• Est. completion date: November 2008

Study information

• Verified date: June 2010
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Tumors

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
15 Gy in one treatment
• Stereotactic Body Radiation Therapy
Dose: 70 Gy at 2.8 Gy/treatment

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Local Control	Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery	1 year	No
Secondary	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	No
Secondary	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	Yes
Secondary	Overall One Year Survival	Number of patients alive at one year after treatment	One year	No