Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00631670

Purpose

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy 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.

Condition	Intervention
Spinal Tumors	Radiation: Stereotactic Body Radiation Therapy

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Further study details as provided by University of Florida:

Estimated Enrollment:	550
Study Start Date:	October 2005

Arms	Assigned Interventions
1: Experimental 15 Gy dose in one treatment	Radiation: Stereotactic Body Radiation Therapy 15 Gy in one treatment
2: Experimental 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 Dose: 70 Gy at 2.8 Gy/treatment

Detailed Description:

This protocol is a study of the use of 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 MR or CT scan
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 MR 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631670

Contacts

Contact: Robert J Amdur, MD

265-0287

amdurrj@shands.ufl.edu

Locations

United States, Florida
University of Florida Shands Cancer Center	Recruiting
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Robert J Amdur, MD

University of Florida- Radiation Oncology

More Information

No publications provided

Study ID Numbers:	IRB # 404-2005
Study First Received:	February 29, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00631670 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Bone Neoplasms
Spinal Cord Diseases
Spinal Cord Neoplasm
Central Nervous System Diseases

Spinal Cord Neoplasms
Central Nervous System Neoplasms
Bone Diseases
Spinal Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Spinal Diseases
Spinal Cord Diseases
Bone Neoplasms
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Bone Diseases

Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Spinal Cord Neoplasms
Spinal Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009