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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01527292
First received: February 2, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Vertebral Metastasis
Radiation: Stereotactic Radiation Therapy
Radiation: SRT with Vertebral Augmentation Procedure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Numerical Rating Pain Scale (NRPS) Change in Patients [ Time Frame: For 6 months post treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Reduction of Pain Estimate [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
    To estimate the relative quantitative reduction of pain from baseline in patients in each arm.

  • Quality of Life Estimate [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
    To estimate the quality of life using the Oswestry Disability Questionnaire

  • Feasibility Rate Estimation [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
    To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).

  • Toxicity Rate Estimation [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: Yes ]
    To estimate the toxicities of the treatment

  • Vertebra Measurement [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
    To measure the dimensions of the treated vertebra(e) at 1 year


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Stereotactic Radiosurgery
Experimental: Treatment Group
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 Name: Stereotactic Radiosurgery with VAP

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527292

Contacts
Contact: Teresa Roberts, RN 502-333-6934
Contact: Shiao Woo, MD 502-562-4360

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Teresa Roberts, RN    502-333-6934      
Contact: Shiao Woo, MD    502-562-4360      
Principal Investigator: Shiao Y Woo, MD         
Sub-Investigator: Douglas Coldwell, MD         
Sub-Investigator: Heidi Koenig, MD         
Sub-Investigator: Shesh Rai, PhD.         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Shiao Y Woo, MD James Graham Brown Cancer Center
  More Information

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01527292     History of Changes
Other Study ID Numbers: BCC-RAD-11-01
Study First Received: February 2, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
Vertebral Metastasis
pain control
VAP
SRT+VAP

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014