Study on Preventive Radiation Therapy for Patients with Mildly Symptomatic Spinal Cancer Spread

Sponsor: Baptist Health South Florida

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05534321

Provider View

This clinical trial is exploring whether early radiation therapy can help prevent complications in patients with spinal cancer that is not causing significant symptoms. The study aims to see if this approach can reduce the risk of serious bone-related issues and hospitalizations.

Patient Parameters

Program Overview

This study is investigating whether giving radiation therapy early to patients with spinal cancer that is not causing major symptoms can help prevent serious bone problems. The goal is to see if this early treatment can improve quality of life and reduce the need for hospital visits. The trial focuses on patients whose cancer has spread to the spine but is not yet causing severe pain or requiring strong pain medications.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a solid tumor cancer with more than 5 areas where the cancer has spread, as seen on imaging tests.
  • Have high-risk bone metastases in the spine that are not causing significant symptoms and do not require opioid pain medication. High-risk metastases include:
    • Largest spinal bone disease areas 2 cm or larger.
    • Disease located at critical spine junctions, such as the top of the spine or lower back.
    • Disease involving certain spine joints.
    • Significant vertebral body compression.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Be 18 years or older.
  • Be able to understand and agree to the study by providing informed consent.
  • Agree to use effective birth control if of reproductive potential. Women must not be pregnant or breastfeeding.

Exclusion Criteria

  • Have had previous radiation therapy to the area planned for treatment that would prevent safe treatment.
  • Have serious medical conditions that would make radiation therapy unsafe.
  • Be pregnant or breastfeeding.
  • Have complicated bone metastases, such as those causing spinal cord compression or at risk of breaking.
  • Have cancer spread to the membranes covering the brain and spinal cord (leptomeningeal disease).
  • Have a treatment plan that would be delayed unacceptably by joining the trial.

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