Clinical trial NCT01527292: Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Official title: Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vertebral Metastasis
Keywords: Vertebral Metastasis
pain control
VAP
SRT+VAP
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2012-02-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 post-treatment

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. ECOG performance status 0-1.
3. Known histologically proven malignancy.
4. 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).
5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
7. Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
8. The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
9. Patients must provide study specific informed consent prior to study entry.
10. 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:

1. Non-ambulatory patients.
2. Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
3. Osteoblastic vertebral metastasis.
4. Prior radiation to the index spine.
5. Patients with rapid neurologic decline.

Primary outcomes:
measure: Numerical Rating Pain Scale (NRPS) Change in Patients
timeFrame: For 6 months post treatment
Secondary outcomes:
measure: Reduction of Pain Estimate
timeFrame: For 1 year post treatment
measure: Quality of Life Estimate
timeFrame: For 1 year post treatment
measure: Feasibility Rate Estimation
timeFrame: For 1 year post treatment
measure: Toxicity Rate Estimation
timeFrame: For 1 year post treatment
measure: Vertebra Measurement
timeFrame: For 1 year post treatment
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Shiao Y Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: