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

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ClinicalTrials.gov Identifier: NCT01527292
Recruitment Status : Terminated (Unable to enroll)
First Posted : February 7, 2012
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Vertebral Metastasis Radiation: Stereotactic Radiation Therapy Radiation: SRT with Vertebral Augmentation Procedure Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : February 2012
Primary Completion Date : May 2, 2015
Study Completion Date : September 2, 2015
Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Quality of Life Estimate [ Time Frame: For 1 year post treatment ]
    To estimate the quality of life using the Oswestry Disability Questionnaire

  3. 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).

  4. Toxicity Rate Estimation [ Time Frame: For 1 year post treatment ]
    To estimate the toxicities of the treatment

  5. Vertebra Measurement [ Time Frame: For 1 year post treatment ]
    To measure the dimensions of the treated vertebra(e) at 1 year


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527292


Locations
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
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

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01527292     History of Changes
Other Study ID Numbers: BCC-RAD-11-01
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: January 2016

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