Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Study Overview
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Brief Summary
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The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Official Title
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A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)

Conditions
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Spinal Metastases

Intervention / Treatment
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* Radiation: Single-fraction spine SRS
* Radiation: Multi-fraction spine SRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment. Patients will have 1 to 3 separate spinal sites that require treatment. Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels ECOG 0-2 Negative serum or urine pregnancy test within 14 days prior to enrollment for women of childbearing potential or who are not postmenopausal Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document Exclusion Criteria: Prior or planned radiation off study within or overlapping with study treatment site Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded Histology's of myeloma or lymphoma Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated Prior surgery to spinal site intended to be treated with protocol SRS Excluded those with SINS 13-18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-fraction spine SRS<br>Single-fraction spine SRS (22 Gy x 1) | Radiation: Single-fraction spine SRS<br>* Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)<br>|
| Experimental: Multi-fraction spine SRS<br>Multi-fraction spine SRS (14 Gy x 2) | Radiation: Multi-fraction spine SRS<br>* Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control | To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euro-QOL EQ-5D-3L health-related quality of life questionnaire | To compare health-related quality of life (EQ-5D-3L) following SRS and assess patient-reported health related quality of life pertaining to mobility, self-care, usual activities, pain, and anxiety. | 2 years | 
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score | To compare health-related quality of life (EORTC QLQ-C30) following SRS and assess patient-reported health related quality of life pertaining to overall health and quality of daily life. | 2 years | 
| EORTC QLQ-BM22 health-related quality of life questionnaire | To compare health-related quality of life (EORTC QLQ-BM22) following SRS and assess patient-reported health related quality of life pertaining to pain associated with performing activities of daily life. | 2 years | 
| Pain Score | Pain associated with the treated area will be assessed by asking patients to rate their pain on a 0-10 scale (no pain to pain as bad as you can imagine) | 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS | 
| Medication Intake | Collect medications taken within the last 24 hours. | 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS | 
| Number of participants with CTCAE grade grade 2 or higher adverse effects | To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS | 1 year | 
| Rate of vertebral compression fracture | To determine 1-year rate of vertebral compression fracture (VCF), following SRS | 1 year | 
| Rate of local failure | To determine 2-year rate of local failure following SRS | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar, thoracic, metastases, spine stereotactic radiosurgery, cervical