Study on Radiation Therapy for Cancer Spread to the Spine

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05617716

Provider View

This clinical trial is comparing three types of radiation therapy to find the best way to treat cancer that has spread to the spine. Participants will be randomly assigned to receive one of the three treatments: External Beam Radiation Therapy (EBRT), standard dose Stereotactic Body Radiation Therapy (SBRT), or higher dose SBRT.

Patient Parameters

Program Overview

The study aims to compare three different radiation treatments for cancer that has spread to the spine. These treatments include External Beam Radiation Therapy (EBRT) and two types of Stereotactic Body Radiation Therapy (SBRT) with different doses. The goal is to determine which treatment is most effective in reducing pain and improving pain relief for patients.

Description

Cancer that spreads to the spine is becoming more common, and radiation therapy is the main treatment. Traditionally, External Beam Radiation Therapy (EBRT) has been used, but it often provides limited pain relief. As patients with metastatic cancer live longer, there is a need for more effective treatments. Stereotactic Body Radiation Therapy (SBRT) is a newer method that delivers higher doses of radiation more precisely to the tumor, potentially sparing surrounding healthy tissue. This study will compare EBRT with standard and higher dose SBRT to see which is better at reducing pain and improving quality of life for patients with spinal metastases.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cancer that has spread to the spine, verified by imaging.
  • Must not have received any previous treatments for this condition, including radiation therapy that overlaps with the area to be treated.
  • Must be over 18 years old and able to give informed consent.
  • Must have a life expectancy of at least 3 months, as determined by the study doctor.
  • Must have a pain score of less than 2 out of 10 on the pain scale.
  • Must not plan to change pain medications on the first day of SBRT.
  • Must have a Spinal Instability score of 12 or less.
  • Must be considered a suitable candidate for spine SBRT by the Radiation Oncology team.
  • Must be able to understand and sign a written consent form.

Exclusion Criteria

  • Currently receiving any other experimental treatments.
  • Have a life expectancy of less than 3 months.
  • Have uncontrolled health issues like active infections, heart failure, unstable chest pain, irregular heartbeats, or mental health issues that would interfere with the study.
  • Pregnant or breastfeeding, due to the risks of radiation therapy.
  • Unable to have an MRI of the spine.
  • Have a Spinal Instability score greater than 12.
  • Have had previous stereotactic radiosurgery that overlaps with the current treatment area.
  • Have more than 3 consecutive vertebrae in the treatment area.
  • Not considered a suitable candidate for SBRT by the Radiation Oncology team.
  • Have a known primary cancer with a survival estimate of 3 months or less.
  • Have an unknown primary cancer.
  • Have a pain score greater than 2 on the pain scale.
  • Have had previous radiation therapy in the area to be treated.
  • Have had previous spinal surgery in the treatment area, except for a biopsy.
  • Have nerve damage from cancer compressing the spinal cord or nerves.

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