A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00802659

Purpose

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.

Condition	Intervention	Phase
Metastases	Radiation: Stereotactic radiotherapy	Phase I Phase II

MedlinePlus related topics: Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Radiation: Stereotactic radiotherapy This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced. Group 1 Radiation Dose 1000 cGy Group 2 Radiation Dose 1200 cGy Group 3 Radiation Dose 1400 cGy Group 4 Radiation Dose 1600 cGY

Arms

Assigned Interventions

1: Experimental

Radiation: Stereotactic radiotherapy

This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.

Group 1 Radiation Dose 1000 cGy Group 2 Radiation Dose 1200 cGy Group 3 Radiation Dose 1400 cGy Group 4 Radiation Dose 1600 cGY

Detailed Description:

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802659

Contacts

Contact: Jeffrey Bradley, M.D.

314-362-8525

bradley@radonc.wustl.edu

Locations

United States, Missouri
Washington University	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Judy Johson 314-362-6045 johnsonj@ccadmin.wustl.edu
Principal Investigator: Jeffrey Bradley, M.D.

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Jeffrey Bradley, M.D.

Washington University School of Medicine

More Information

Additional Information:

(AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Washington University ( Jeffrey Bradley, M.D. )
Study ID Numbers:	07-1149
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802659 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neoplasm Metastasis
Pain

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 07, 2009