Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-fraction spine SRS, Multi-fraction spine SRS.
- Who it may be relevant to
- Registry conditions: Spinal Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Overview
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.
Interventions
- Radiation Single-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1) - Radiation Multi-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Primary outcome measures
- Tumor control [Time frame: 1 year]
Secondary outcome measures (8)
- Euro-QOL EQ-5D-3L health-related quality of life questionnaire [Time frame: 2 years]
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score [Time frame: 2 years]
- EORTC QLQ-BM22 health-related quality of life questionnaire [Time frame: 2 years]
- Pain Score [Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS]
- Medication Intake [Time frame: 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 [Time frame: 1 year]
- Rate of vertebral compression fracture [Time frame: 1 year]
- Rate of local failure [Time frame: 2 years]
Eligibility criteria
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 people of childbearing potential or who are not postmenopausal
- people 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University School of Medicine — Palo Alto
Identifiers
NCT: NCT06173401 · IRB-72248 · BRN0060 · NCI-2024-00695