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NCT Number: NCT06165419

Definitive Radiation for High-Risk Spine Metastases

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

Recruiting

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Key information

Conditions

Metastatic Cancer Bone Diseases Bone Neoplasms Breast Diseases Breast Neoplasms Lung Diseases Lung Neoplasms Metastasis Metastatic Breast Cancer Metastatic Lung Cancer Metastatic Tumor Metastatic Tumor of Bone Metastatic Tumor to the Spine Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Spine Metastases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Caterina Vacchi-Suzzi, PhD

CONTACT

[email protected]

631-216-2993

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SBRT to the spine

Radiation

Stereotactic body radiation therapy (SBRT) administered to spine metastases

Primary outcomes

  1. Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT

    Time frame: 6 months

    Assess the efficacy of spine SBRT alone in controlling spine metastases

Secondary outcomes

  1. Reduction in epidural tumor volume

    Time frame: 3 months

    Percent reduction of epidural volume of the treated metastatic lesions

  2. Changes on Neck Disability index

    Time frame: 1 months, 3 months, 6 months

    The Neck Disability Index measures neck pain and disabilities in patients with neck pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.

  3. Changes on Oswestry Low Back Disability Questionnaire

    Time frame: 1 months, 3 months, 6 months

    The Oswestry Disability Index measures disability in patients with low back pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.

  4. Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire

    Time frame: 1 months, 3 months, 6 months

    The EuroQol 5D-5L questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health dimension is scored from 1 to 5, with 1 indicating a better health state, and 5 the worse state possible. Respondents also indicate their overall health status on visual analogue score, with values ranging from 0 (worst health imaginable) to 100 (best health imaginable)

  5. Progression-free survival

    Time frame: 6 months

  6. Overall survival

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hermina Munoz, RN

CONTACT

[email protected]

631-216-2990

Lucia Joya

CONTACT

[email protected]

631-216-2998

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • The University of Texas Health Science Center at San Antonio

Registry information

Official study title

A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
May 14, 2025

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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