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Search / Trial NCT06165419

Definitive Radiation for High-Risk Spine Metastases

Launched by STONY BROOK UNIVERSITY · Dec 1, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment option for patients with cancer that has spread to the spine. Specifically, it is looking at whether using a targeted type of radiation therapy, known as stereotactic body radiation therapy, can effectively treat spine tumors without needing major surgery. This study aims to help those with aggressive metastatic cancers, including lung and breast cancers, by offering a less invasive approach.

To participate in this trial, patients should have a solid tumor (not originating in the brain) that has been confirmed by medical tests, along with evidence that it has spread to the spine. Eligible patients must have up to three affected vertebrae and maintain good nerve function or only minor issues. It’s important for potential participants to have an assessment by specialists in radiation and spine surgery. Those with certain conditions, like an unstable spine or previous treatments for the same area, will not qualify. If you decide to join, you can expect close monitoring and care from the medical team throughout the treatment process.

Gender

ALL

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)

About Stony Brook University

Stony Brook University, a prominent research institution located in New York, is dedicated to advancing medical science through innovative clinical trials and research initiatives. As a sponsor, Stony Brook University leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient care and health outcomes. With a commitment to ethical standards and collaborative partnerships, the university fosters an environment conducive to groundbreaking discoveries and the translation of research findings into clinical practice.

Locations

Stony Brook, New York, United States

Patients applied

0 patients applied

Trial Officials

Kartik Mani, MD PhD

Principal Investigator

Stony Brook Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported