Expired Study
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St. Louis, Missouri 63110


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).


Study summary:

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.


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 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


NCT ID:

NCT00593320


Primary Contact:

Principal Investigator
Jeffrey Bradley, MD
Washington University School of Medicine


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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