A Study of Preventive Radiation Therapy for Patients with High-Risk Bone Metastases that Are Not Causing Significant Pain

Full Title

A Randomized Trial of Early, Upfront Palliative Radiation Therapy versus Standard of Care for Patients with Highest Risk Asymptomatic or Minimally Symptomatic Bone Metastases

Purpose

The standard treatment for most patients with metastatic cancer to bone that are not causing significant pain is chemotherapy or observation. Radiation therapy is often used to treat cancers in the bone that are causing pain. Early intervention with radiation to some bone metastases before they become painful may prevent complications such as fractures caused by tumors in the bone, a tumor displacing the spinal cord, and significant bone pain that would otherwise be relieved by palliative radiation or surgery.

Some bone metastases are more prone to cause pain requiring radiation, including those in the spine, hip, shoulder, and long bones, and larger bone tumors. These are considered “high-risk” bone metastases. The purpose of this study is to compare the outcome of patients who receive preventative radiation and then standard treatment for bone metastases with those who receive standard treatment alone.

Patients will be randomly assigned to receive standard treatment alone or standard treatment preceded by preventive radiation therapy. Patients in both groups will have the option of receiving radiation if they have metastases that cause symptoms such as pain.

Eligibility

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

  • Patients must have a solid tumor that has spread to more than five sites in the body, with high-risk bone metastases that are not causing significant symptoms.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. T. Jonathan Yang at 212-639-8157.

Protocol

18-196

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators