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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00631670
First received: February 29, 2008
Last updated: February 1, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention
Spinal Tumors
Radiation: Stereotactic Body Radiation Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Local Control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery

  • Neurologic Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Pain Relief [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Overall One Year Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of patients alive at one year after treatment


Enrollment: 21
Study Start Date: October 2005
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Treatment Group
15 Gy dose in one stereotactic body radiation treatment
Radiation: Stereotactic Body Radiation Therapy
15 Gy in one 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
Dose: 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

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of Florida
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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00631670     History of Changes
Other Study ID Numbers: IRB # 404-2005
Study First Received: February 29, 2008
Results First Received: November 28, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Neoplasms
Spinal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on July 24, 2014