A Phase III Study of Post-Surgical Stereotactic Radiotherapy versus Gamma Tiles to Treat Newly Diagnosed Brain Metastases

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Full Title

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors (WIRB)

Purpose

Stereotactic radiotherapy is a treatment used for people with brain metastases, including the cavity left in the brain after a tumor has been removed surgically. The GammaTile is an FDA-cleared device used to provide radiation therapy following the removal of a brain tumor. The tiles contain sources of radiation that look like grains of rice. The tiles are placed in the cavity after brain tumor removal. They are left in place and eventually absorbed by the body.

In this study, researchers are comparing the effectiveness of GammeTile therapy versus conventional stereotactic radiotherapy in people newly diagnosed with brain metastases. Participants will be randomly assigned to receive either GammeTiles (placed during surgery) or stereotactic radiotherapy (delivered after surgery).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have one to four newly diagnosed brain metastases.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Kathryn Beal at 212-639-5159.

Protocol

21-479

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04365374