Definitive Radiation for High-Risk Spine Metastases

Phase 2RecruitingNCT06165419

Stony Brook University26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Assess the efficacy of spine SBRT alone in controlling spine metastases

Time frame: 6 months

Secondary Outcomes

Reduction in epidural tumor volume

Percent reduction of epidural volume of the treated metastatic lesions

Time frame: 3 months

Changes on Neck Disability index

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.

Time frame: 1 months, 3 months, 6 months

Changes on Oswestry Low Back Disability Questionnaire

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.

Time frame: 1 months, 3 months, 6 months

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

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)

Time frame: 1 months, 3 months, 6 months

Progression-free survival

Time frame: 6 months

Overall survival

Time frame: 6 months

Data from ClinicalTrials.gov

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Definitive Radiation for High-Risk Spine Metastases

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts