A Phase 3 Study Comparing Proton Craniospinal Radiation Therapy With the Usual Radiation Therapy for Leptomeningeal Metastasis

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Full Title

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients with Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM) (NRG-BN014) (CIRB)

Purpose

Breast cancer and non-small cell lung cancer (NSCLC) can spread to the cerebrospinal fluid-filled space around the brain and spinal cord. This is called leptomeningeal metastasis (LM). The effects of LM on the nervous system can be very serious.

The current standard strategy employs x-rays to treat the brain and specific areas of the spine to relieve or prevent symptoms. This is called involved-field radiation therapy (IFRT).

In this study, researchers are comparing usual IFRT with proton craniospinal irradiation (pCSI). pCSI uses proton radiation to comprehensively treat the entire central nervous system space. This includes the cerebrospinal fluid, brain, and spinal cord.

This study is determining whether pCSI is better than IFRT to treat LM in people with breast cancer or NSCLC. If you take part in this study, you will be randomly assigned to get IFRT or pCSI.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have newly diagnosed LM from breast cancer or NSCLC.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information about this study, please call Dr. Yao Yu’s office at 908-542-3427.

Protocol

25-150

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06500481