Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
18 Years
N/A
Both
Spinal Metastases
Trial Information
Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
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.
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 greater 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.
- No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary endpoint of the primary objective is to estimate the pain control rate, function, and quality of life
Outcome Description:
1, 3, and 6 months after treatment
Outcome Time Frame:
6 months after end of treatment
Safety Issue:
Yes
Principal Investigator
Jeffrey Bradley, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
07-0658
NCT ID:
NCT00593320
Start Date:
September 2007
Completion Date:
March 2010
Related Keywords:
- Spinal Metastases
- SRS
- Neoplasm Metastasis
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
