A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Stanford University
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sexua…
Interventions
- RadiationSingle-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
- RadiationMulti-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Location
- Stanford University School of MedicinePalo Alto, California