New proton therapy could outshine standard radiation for deadly cancer complication

NCT ID NCT06500481

Recruiting now Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase III trial tests whether proton craniospinal irradiation (pCSI) can improve survival compared to standard involved-field radiation therapy (IFRT) for patients with breast or non-small cell lung cancer that has spread to the lining of the brain and spinal cord (leptomeningeal metastasis). About 115 participants will be randomly assigned to receive either pCSI or IFRT. The study aims to see if the more precise proton beam can delay disease worsening and extend life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Proton craniospinal irradiation (pCSI) and involved-field radiation therapy (IFRT)
What this could lead to: If pCSI works better, it could offer a new standard treatment that delays worsening of leptomeningeal metastasis and improves survival for patients with breast or lung cancer.
What could go wrong: This is an early-stage phase III trial with only 115 participants, so results may not apply to all patients. Proton therapy is not widely available, and there may be side effects from radiating the entire central nervous system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm lung cancer lung neoplasm Meningeal Carcinomatosis neoplastic meningitis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANATOMIC STAGE IV BREAST CANCER AJCC V8 METASTATIC BREAST CARCINOMA METASTATIC LUNG NON-SMALL CELL CARCINOMA METASTATIC MALIGNANT NEOPLASM IN THE LEPTOMENINGES STAGE IV LUNG CANCER AJCC V8

Contacts and locations

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Locations

Alton Memorial Hospital
RECRUITING

Alton, Illinois, 62002, United States
California Protons Cancer Therapy Center
RECRUITING

San Diego, California, 92121, United States
Huntsman Cancer Institute/University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States

Contact Email: •••••@•••••
Inova Alexandria Hospital
RECRUITING

Alexandria, Virginia, 22304, United States
Inova Fair Oaks Hospital
RECRUITING

Fairfax, Virginia, 22033, United States
Inova Loudoun Hospital
RECRUITING

Leesburg, Virginia, 20176, United States
Inova Schar Cancer Institute
RECRUITING

Fairfax, Virginia, 22031, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING

Baltimore, Maryland, 21287, United States
Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITING

Lansing, Michigan, 48910, United States

Contact Email: •••••@•••••
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING

New York, New York, 10016, United States

Contact Email: •••••@•••••
Mayo Clinic Hospital in Arizona
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic in Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
McLaren Cancer Institute-Flint
RECRUITING

Flint, Michigan, 48532, United States

Contact Email: •••••@•••••
Memorial Hospital East
RECRUITING

Shiloh, Illinois, 62269, United States
Memorial Sloan Kettering Basking Ridge
RECRUITING

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen
RECRUITING

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Memorial Sloan Kettering Commack
RECRUITING

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth
RECRUITING

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau
RECRUITING

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester
RECRUITING

Harrison, New York, 10604, United States
Mercy Hospital South
RECRUITING

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield
RECRUITING

Springfield, Missouri, 65804, United States
Miami Cancer Institute
RECRUITING

Miami, Florida, 33176, United States
Montefiore Medical Center - Moses Campus
RECRUITING

The Bronx, New York, 10467, United States
Montefiore Medical Center-Einstein Campus
RECRUITING

The Bronx, New York, 10461, United States
NYU Langone Hospital - Brooklyn
RECRUITING

Brooklyn, New York, 11220, United States
NYU Langone Hospital - Long Island
RECRUITING

Mineola, New York, 11501, United States

Contact Email: •••••@•••••
New York Proton Center
RECRUITING

New York, New York, 10035, United States
Northwestern Medicine Cancer Center Delnor
RECRUITING

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville
RECRUITING

Warrenville, Illinois, 60555, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
Ohio State University Comprehensive Cancer Center
RECRUITING

Columbus, Ohio, 43210, United States
Sibley Memorial Hospital
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Siteman Cancer Center at Christian Hospital
RECRUITING

St Louis, Missouri, 63136, United States

Contact Email: •••••@•••••
Siteman Cancer Center at Saint Peters Hospital
RECRUITING

City of Saint Peters, Missouri, 63376, United States

Contact Email: •••••@•••••
Siteman Cancer Center at West County Hospital
RECRUITING

Creve Coeur, Missouri, 63141, United States

Contact Email: •••••@•••••
Siteman Cancer Center-South County
RECRUITING

St Louis, Missouri, 63129, United States

Contact Email: •••••@•••••
UC San Diego Health System - Encinitas
RECRUITING

Encinitas, California, 92024, United States
UC San Diego Medical Center - Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92093, United States

Contact Email: •••••@•••••
UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITING

Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
RECRUITING

Doral, Florida, 33166, United States
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING

Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING

Plantation, Florida, 33324, United States
University of Arkansas for Medical Sciences
RECRUITING

Little Rock, Arkansas, 72205, United States
University of Kansas Cancer Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit
RECRUITING

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North
RECRUITING

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center-Overland Park
RECRUITING

Overland Park, Kansas, 66210, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

Contact Email: •••••@•••••
Wayne State University/Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States

Contact Email: •••••@•••••
Weisberg Cancer Treatment Center
RECRUITING

Farmington Hills, Michigan, 48334, United States

Contact Email: •••••@•••••

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