Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Stopped early · Not applicable
Conditions studied: Vertebral Metastasis
In brief
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.
Key facts
- Study ID
- NCT01527292
- Run by
- University of Louisville
- People needed
- 3
- Starts
- 2012-02-01
- Expected to finish
- 2015-09-02
- Last updated by the study team
- 2019-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- James Graham Brown Cancer Center — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.