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Completed

NCT Number: NCT00631670

Stereotactic Body Radiation Therapy (SBRT) 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.

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Key information

Conditions

Spinal Tumors Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

15 Gy in one treatment

Primary outcomes

  1. Toxicity

    Time frame: 2 yrs

    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 outcomes

  1. Local Control

    Time frame: 1 year

    Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery

  2. Neurologic Function

    Time frame: 2 years

    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.

  3. Pain Relief

    Time frame: 12 weeks

    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.

  4. Overall One Year Survival

    Time frame: One year

    Number of patients alive at one year after treatment

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 10, 2008
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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