Clinical trial NCT00631670: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Tumors
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Toxicity
timeFrame: 2 yrs
Secondary outcomes:
measure: Local Control
timeFrame: 1 year
measure: Neurologic Function
timeFrame: 2 years
measure: Pain Relief
timeFrame: 12 weeks
measure: Overall One Year Survival
timeFrame: One year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida- Radiation Oncology
name: Robert J Amdur, MD
role: PRINCIPAL_INVESTIGATOR
References: