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A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
This study is currently recruiting participants.
Study NCT00802659   Information provided by Washington University School of Medicine
First Received: December 4, 2008   No Changes Posted

December 4, 2008
December 4, 2008
December 2007
To determine the optimal dose of stereotactic spinal irradiation needed to obtain durable pain control at 4 weeks in a previously irradiated spine field. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • To determine the duration of pain control for each dose level. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
  • Determine the rate of radiation-induced myelopathy from stereotactic re-irradiation of the spinal metastases. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
  • Determine the pattern of failure after stereotactic irradiation of spinal metastases. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
  • Measure quality of life in patients treated with stereotactic radiotherapy (ESRT) [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
Same as current
 
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation

This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Metastases
Radiation: Stereotactic radiotherapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
December 2013
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18
  • Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
  • Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
  • Have had prior radiation to area of spine felt to be cause of patient's pain
  • Zubrod performance status of 0-3
  • Life expectancy of ≥ 3 months
  • Signed informed consent prior to registration to study
  • Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.

Exclusion Criteria:

  • Women who are pregnant or nursing
  • Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
  • No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
  • No initiation of chemotherapy within 15 days of trial entry.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
  • No active systemic infection.
  • No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Both
18 Years and older
No
Contact: Jeffrey Bradley, M.D. 314-362-8525 bradley@radonc.wustl.edu
United States
 
 
NCT00802659
Jeffrey Bradley, M.D., Washington University
07-1149
Washington University School of Medicine
 
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine
Washington University School of Medicine
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP