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Stereotactic Radiosurgery (SRS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593320
First received: January 2, 2008
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).


Condition Intervention
Spinal Metastases
 Radiation: Stereotactic Radiosurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The primary endpoint of the primary objective is to estimate the pain control rate, function, and quality of life at 1, 3, and 6 months after treatment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The primary endpoint of the secondary objective is to estimate the local control rate at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
 Radiation: Stereotactic Radiosurgery
14 Gy
Active Comparator: 2
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
 Radiation: Stereotactic Radiosurgery
18 Gy

Detailed Description:

This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • Age greater than or equal to 18 years old.
  • Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
  • Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
  • Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
  • Maximum tumor size less than or equal to 5 cm.
  • Zubrod performance status of less than or equal to 3.
  • Life expectancy of less than or equal to 3 months.
  • Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria:

  • No prior radiation delivered to the involved area
  • No evidence of spinal instability requiring urgent surgical intervention.
  • No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
  • No pregnant or lactating women.
  • No active systemic infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593320

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Bradley, MD Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593320     History of Changes
Other Study ID Numbers: 07-0658
Study First Received: January 2, 2008
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
SRS

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013