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

Study Overview
=================
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

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

Conditions
-----------------
Vertebral Metastasis

Intervention / Treatment
-----------------
* Radiation: Stereotactic Radiation Therapy
* Radiation: SRT with Vertebral Augmentation Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. ECOG performance status 0-1. Known histologically proven malignancy. 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). Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control. Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration. The patient must have a score of ≥ 5 for at least one of the planned sites for SRT. Patients must provide study specific informed consent prior to study entry. 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: Non-ambulatory patients. Frank spinal cord compression or epidural compression within 3 mm of the spinal cord. Osteoblastic vertebral metastasis. Prior radiation to the index spine. Patients with rapid neurologic decline.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only | Radiation: Stereotactic Radiation Therapy<br>* SRT only<br>* Other names: Stereotactic Radiosurgery;|
| Experimental: Treatment Group<br>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<br>* SRT with VAP<br>* 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 | 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 | To estimate the relative quantitative reduction of pain from baseline in patients in each arm. | For 1 year post treatment | 
| Quality of Life Estimate | To estimate the quality of life using the Oswestry Disability Questionnaire | For 1 year post treatment | 
| Feasibility Rate Estimation | 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 | To estimate the toxicities of the treatment | For 1 year post treatment | 
| Vertebra Measurement | To measure the dimensions of the treated vertebra(e) at 1 year | For 1 year post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertebral Metastasis, pain control, VAP, SRT+VAP