A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
Primary Purpose
Metastases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastases
Eligibility 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
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group -1
Group 1
Group 2
Group 3
Arm Description
1000 cGY radiation
1200 cGY radiation
1400 cGY radiation
1600 cGY radiation
Outcomes
Primary Outcome Measures
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Optimal dose
the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications
the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Secondary Outcome Measures
Duration of Pain Control for Each Dose Level.
A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Quality of Life
As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)
Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
Full Information
NCT ID
NCT00802659
First Posted
December 4, 2008
Last Updated
November 18, 2014
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00802659
Brief Title
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group -1
Arm Type
Experimental
Arm Description
1000 cGY radiation
Arm Title
Group 1
Arm Type
Experimental
Arm Description
1200 cGY radiation
Arm Title
Group 2
Arm Type
Experimental
Arm Description
1400 cGY radiation
Arm Title
Group 3
Arm Type
Experimental
Arm Description
1600 cGY radiation
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Other Intervention Name(s)
Stereotactic Radiosurgery, Paraspinal Metastasis, Prior Spinal Irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Description
Optimal dose
the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications
the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Duration of Pain Control for Each Dose Level.
Description
A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
Time Frame
4 years
Title
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Time Frame
4 weeks
Title
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Time Frame
4 years
Title
Quality of Life
Description
As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)
Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bradley, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
(AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
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