NCT06173401 Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
| NCT ID | NCT06173401 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stanford University |
| Condition | Spinal Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 274 participants in total. It began in 2023-12-18 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Erqi Pollom, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06173401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06173401 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 274 participants.
Is NCT06173401 currently recruiting?
Yes, NCT06173401 is actively recruiting participants. Contact the research team at kelhuang@stanford.edu for enrollment information.
Where is the NCT06173401 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06173401 clinical trial?
NCT06173401 is sponsored by Stanford University. The principal investigator is Erqi Pollom, MD at Stanford University. The trial plans to enroll 274 participants.