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

Not Applicable

Terminated

• Conditions: Vertebral Metastasis
• Interventions: Radiation: Stereotactic Radiation Therapy; Radiation: SRT with Vertebral Augmentation Procedure

• Registration Number: NCT01527292
• Lead Sponsor: University of Louisville

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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Primary Completion: 2015-05-02
• Study Completion: 2015-09-02
• Status Verified: 2016-01
• Results First Submitted: 2019-01-14
• Results First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Results First Posted: 2019-02-05
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Stereotactic Radiation Therapy	Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only
Treatment Group	SRT with Vertebral Augmentation Procedure	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

Primary Outcome Measures

Name	Time	Method
Numerical Rating Pain Scale (NRPS) Change in Patients	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

Name	Time	Method
Vertebra Measurement	For 1 year post treatment	To measure the dimensions of the treated vertebra(e) at 1 year
Reduction of Pain Estimate	For 1 year post treatment	To estimate the relative quantitative reduction of pain from baseline in patients in each arm.
Feasibility Rate Estimation	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).
Toxicity Rate Estimation	For 1 year post treatment	To estimate the toxicities of the treatment
Quality of Life Estimate	For 1 year post treatment	To estimate the quality of life using the Oswestry Disability Questionnaire

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States