- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527292
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
January 14, 2019 updated by: Shiao Yuo Woo, University of Louisville
Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Known histologically proven malignancy.
- Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
- Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
- The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
- Patients must provide study specific informed consent prior to study entry.
- Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).
Exclusion Criteria:
- Non-ambulatory patients.
- Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
- Osteoblastic vertebral metastasis.
- Prior radiation to the index spine.
- Patients with rapid neurologic decline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Baseline Assessments and followup assessments are the same for both arms.
Control group Intervention: Stereotactic Radiation Therapy only
|
SRT only
Other Names:
|
Experimental: Treatment Group
SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms.
Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure
|
SRT with VAP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Pain Scale (NRPS) Change in Patients
Time Frame: For 6 months post treatment
|
To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score
|
For 6 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of Pain Estimate
Time Frame: For 1 year post treatment
|
To estimate the relative quantitative reduction of pain from baseline in patients in each arm.
|
For 1 year post treatment
|
Quality of Life Estimate
Time Frame: For 1 year post treatment
|
To estimate the quality of life using the Oswestry Disability Questionnaire
|
For 1 year post treatment
|
Feasibility Rate Estimation
Time Frame: For 1 year post treatment
|
To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).
|
For 1 year post treatment
|
Toxicity Rate Estimation
Time Frame: For 1 year post treatment
|
To estimate the toxicities of the treatment
|
For 1 year post treatment
|
Vertebra Measurement
Time Frame: For 1 year post treatment
|
To measure the dimensions of the treated vertebra(e) at 1 year
|
For 1 year post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shiao Y Woo, MD, James Graham Brown Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Actual)
May 2, 2015
Study Completion (Actual)
September 2, 2015
Study Registration Dates
First Submitted
February 2, 2012
First Submitted That Met QC Criteria
February 6, 2012
First Posted (Estimate)
February 7, 2012
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCC-RAD-11-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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