A Phase I Study of Single-Dose Radiation Therapy to Treat Spine Metastases that Have Been Irradiated Before

Full Title

A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery

Purpose

Treating cancer in the spine with a single high dose of radiation therapy has been shown to be more effective than a longer course of radiation therapy with multiple treatments. However, doctors have not yet evaluated the use of single-dose radiation therapy in people with cancer in the spine that has already been treated with radiation therapy. They want to identify the highest dose that can be given while sparing the spinal cord from injury.

The purpose of this study is to find the highest dose of single-dose radiation therapy that can be given safely to patients with cancer that has spread to the spine from other sites (metastases) and has continued to grow. Researchers will try different doses in different patients, with each patient receiving just one dose. The radiation therapy given in this study is called image-guided stereotactic radiosurgery, which finely targets the radiation to the cancer while sparing as much nearby healthy tissue as possible.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have spinal metastases that have continued to grow despite having been treated with radiation therapy at least 6 months before entering the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Yoshiya (Josh) Yamada at 212-639-2950.

Protocol

14-054

Phase

I

Investigator

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