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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-02

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Vertebral Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

Group Type ACTIVE_COMPARATOR

Stereotactic Radiation Therapy

Intervention Type RADIATION

SRT only

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

Group Type EXPERIMENTAL

SRT with Vertebral Augmentation Procedure

Intervention Type RADIATION

SRT with VAP

Interventions

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Stereotactic Radiation Therapy

SRT only

Intervention Type RADIATION

SRT with Vertebral Augmentation Procedure

SRT with VAP

Intervention Type RADIATION

Other Intervention Names

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Stereotactic Radiosurgery Stereotactic Radiosurgery with VAP

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No