A Pilot Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People with Cancer That Has Spread to the Bone

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Full Title

A Pilot Study to Assess the Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy for the Treatment of Metastatic Disease in Bone Requiring Surgical Stabilization

Purpose

When cancer spreads to the bones, it can weaken them and make them prone to fractures. The most common standard treatment to prevent these fractures is surgical stabilization using plates, screws, or rods to reinforce the bone, followed by radiation therapy to treat the cancer. However, people may experience tumor recurrence, problems with the metal implants, or infection and need additional surgery or radiation.

In this study, researchers are assessing the use of stereotactic body radiotherapy (SBRT) before surgical stabilization. SBRT is an alternative type of radiation therapy that delivers very precisely targeted high-dose radiation in less time than standard radiation therapy. Researchers in this study are assessing pre-operative SBRT followed by surgical stabilization within 1 week in patients at risk for fractures due to bone metastases. They believe this approach may reduce tumor recurrence, prevent the need for additional surgery or radiation, and reduce delays in starting other cancer treatments.

Who Can Join

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

  • Patients must have cancer that has spread to bones in the arms, legs, and/or pelvis that requires surgical stabilization.
  • Patients may not have previously received radiation to or had surgical treatment of these sites.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Maksim Vaynrub at 212-639-7038.

Protocol

21-216

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05038124