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Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

Phase 2
18 Years
Open (Enrolling)
Vertebral Metastasis

Thank you

Trial Information

Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Numerical Rating Pain Scale (NRPS) Change in Patients

Outcome Description:

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

Outcome Time Frame:

For 6 months post treatment

Safety Issue:


Principal Investigator

Shiao Y Woo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

April 2014

Related Keywords:

  • Vertebral Metastasis
  • Vertebral Metastasis
  • pain control
  • VAP
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



James Graham Brown Cancer Center Louisville, Kentucky  40202