NCT06165419 Definitive Radiation for High-Risk Spine Metastases
| NCT ID | NCT06165419 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stony Brook University |
| Condition | Metastatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2026-05-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2023-12-14 with a primary completion date of 2026-05-31.
⚠ 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
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
Eligibility Criteria
Eligible patients must have: * Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease * Metastatic spine involvement documented by imaging * Involvement of maximum 3 contiguous vertebral bodies at the index site * Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids * An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending * ECOG Performance Status of 0-3 Patients are ineligible if they have: * An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12 * Had previous surgery or radiation to address the target spinal metastases * Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Contact & Investigator
Kartik Mani, MD PhD
PRINCIPAL INVESTIGATOR
Stony Brook Cancer Center
Frequently Asked Questions
Who can join the NCT06165419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Cancer. 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 NCT06165419 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06165419 currently recruiting?
Yes, NCT06165419 is actively recruiting participants. Contact the research team at hermina.munoz@stonybrookmedicine.edu for enrollment information.
Where is the NCT06165419 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT06165419 clinical trial?
NCT06165419 is sponsored by Stony Brook University. The principal investigator is Kartik Mani, MD PhD at Stony Brook Cancer Center. The trial plans to enroll 26 participants.
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