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

  • United States
    • 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:

  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.

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
Radiation: Stereotactic Radiation Therapy
SRT only
Other Names:
  • Stereotactic Radiosurgery
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
Radiation: SRT with Vertebral Augmentation Procedure
SRT with VAP
Other Names:
  • Stereotactic Radiosurgery with VAP

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

University of Louisville

Collaborators

James Graham Brown Cancer Center

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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