Stanford University School of Medicine
Palo Alto, California, 94305, United States
Location status: Recruiting
Location contact
Alyssa Yauger
CONTACT
Erqi L Pollom, M.D.
PRINCIPAL_INVESTIGATOR
Kelly Huang
CONTACT
NCT Number: NCT06173401
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Palo Alto, California, 94305, United States
Location status: Recruiting
Alyssa Yauger
CONTACT
Erqi L Pollom, M.D.
PRINCIPAL_INVESTIGATOR
Kelly Huang
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
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")
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Collect medications taken within the last 24 hours.
Time frame: 1 year
To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS
Time frame: 1 year
To determine 1-year rate of vertebral compression fracture (VCF), following SRS
Time frame: 2 years
To determine 2-year rate of local failure following SRS
Contact information is provided by the study sponsor or research team.
Alyssa Yauger
CONTACT
Kelly Huang
CONTACT
Stanford University
Other
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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