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Definitive Radiation for High-Risk Spine Metastases

Stony Brook University logo

Stony Brook University

Status and phase

Enrolling
Phase 2

Conditions

Metastatic Tumor
Metastatic Cancer
Metastasis
Metastatic Tumor to the Spine
Metastatic Tumor of Bone
Metastatic Breast Cancer
Spine Metastases
Metastatic Lung Cancer

Treatments

Radiation: SBRT to the spine

Study type

Interventional

Funder types

Other

Identifiers

NCT06165419
SBU-RT-MESCC
IRB2023-00421 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

SBRT to the spine
Experimental group
Treatment:
Radiation: SBRT to the spine

Trial contacts and locations

1

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Central trial contact

Hermina Munoz, RN; Lucia Joya

Data sourced from clinicaltrials.gov

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