Single vs. Multiple Dose Spine Radiosurgery for Previously Treated Spinal Cancer Spread

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03028337

Provider View

This study is exploring whether giving spine radiosurgery in one large dose is more effective than spreading it over three smaller doses for patients with spinal cancer that has already been treated with radiation.

Patient Parameters

Program Overview

The purpose of this study is to find out if delivering spine radiosurgery in a single large dose is better than giving it in three smaller doses for patients with spinal metastases that have been previously treated with radiation. Researchers also want to understand how a single dose affects symptoms, pain, and quality of life.

Description

In this study, participants will be randomly assigned to one of two groups. One group will receive spine radiosurgery in a single large dose, while the other group will receive it over three smaller doses, which is the standard approach.

Participants will continue in the study as long as it is beneficial for them, but will stop if the disease worsens, side effects become intolerable, or they cannot follow the study directions.

After the radiosurgery, participants will have follow-up visits at 3, 6, 9, 12, 18, and 24 months, and then every 6 months. During these visits, they will have a physical and neurological exam, complete questionnaires, and have an MRI scan.

This study is considered investigational because giving spine radiosurgery in a single large dose is not yet a standard treatment. Up to 80 participants will be enrolled, all at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a solid tumor cancer that has spread to the spine.
  • Must be 18 years or older.
  • Must be in relatively good health, able to perform daily activities with some limitations.
  • Must have a life expectancy of more than 6 months.
  • Must be able to lie on their back.
  • Must have no more than 3 connected or separate vertebral body levels treated.
  • Must show cancer progression at a spinal site previously treated with radiation more than 6 months ago.
  • Must have received prior radiation therapy to the site of interest within specific dose limits.
  • Must have a vertebral body site to be treated located between T1 and L5.
  • Women of childbearing potential and men must agree to use effective birth control during the study.
  • Must sign informed consent acknowledging the investigational nature of the study.
  • Previous surgery or laser therapy is allowed.
  • Open to all genders, races, and ethnic groups.

Exclusion Criteria

  • Cannot undergo an MRI of the spine.
  • Received radiation at the site of interest within the last 6 months.
  • Previous radiation at the site resulted in a dose exceeding specific limits.
  • Cannot lie flat comfortably for 2 hours.
  • Pregnant women are excluded due to potential risks from radiation.
  • Patients with lymphoma or myeloma are excluded.

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