Status:
TERMINATED
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Vertebral Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01527292
Start Date
February 1 2012
End Date
September 2 2015
Last Update
February 5 2019
Active Locations (1)
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1
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202