Proton beam vs. X-Ray radiation: which is better for esophageal cancer?

NCT ID NCT03801876

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

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 6 times

Summary

This study compares two radiation techniques for people with stage I to IVA esophageal cancer: proton beam therapy (which uses protons) and intensity modulated photon radiotherapy (which uses X-rays). The goal is to see which one works better at helping people live longer and causes fewer serious heart and lung side effects. About 300 participants will be randomly assigned to one of the two treatments, and some may also receive chemotherapy.

What this could mean

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

Active substance: Proton beam therapy (PBT) and intensity modulated photon radiotherapy (IMRT)
What this could lead to: If proton therapy works better, it could become a new standard treatment for esophageal cancer, offering longer survival with fewer heart and lung complications.
What could go wrong: This is a large phase 3 trial, but results are not guaranteed. Proton therapy may not prove superior to standard radiation, and side effects or logistical challenges could limit its use.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Nov 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II) * Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup: * History/physical examination * Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast * For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration * For patients who DID receive induction chemotherapy, scan must occur: * Within 30 days after final induction chemotherapy dose; OR * Within 30 days prior to Step 1 registration * Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible * Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation * Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration; only FOLFOX, CAPOX, durvalumab-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) (D-FLOT) and FLOT will be allowed as the induction chemotherapy regimen * Age ≥ 18 * Zubrod performance status 0, 1, or 2 * Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration) * For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm\^3 * For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm\^3 * Platelets (within 30 days prior to Step 1 registration) * For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL * For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration) * Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \> 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration) * Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: * Cervical esophageal cancers arisen from 15-18 cm from the incisors * Patients with T4b disease according to the AJCC 8th edition * Definitive clinical or radiologic evidence of metastatic disease * Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment * Prior thoracic radiotherapy that would result in overlap of radiation therapy fields * Severe, active co-morbidity defined as follows: * Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration * Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration * Myocardial infarction within 3 months prior to Step 1 registration * Pregnant and/or nursing females * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive * PRIOR TO STEP 2 REGISTRATION: * Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment

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Conditions

The condition(s) this trial relates to.

esophageal adenocarcinoma esophageal squamous cell carcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Contacts and locations

Locations

Alton Memorial Hospital

Alton, Illinois, 62002, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States
Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States
Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States
Covenant Health Cancer Centers

Knoxville, Tennessee, 37916, United States
Covenant Health Cancer Centers - West

Knoxville, Tennessee, 37932, United States
Covenant Health Oncology Group - Maryville

Maryville, Tennessee, 37804, United States
Covenant Health Oncology Group - Oak Ridge

Oak Ridge, Tennessee, 37830, United States
Covenant Health Proton Center

Knoxville, Tennessee, 37909, United States
Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Geauga Hospital

Chardon, Ohio, 44024, United States
Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Inova Alexandria Hospital

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

Fairfax, Virginia, 22033, United States
Inova Loudoun Hospital

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

Fairfax, Virginia, 22031, United States
Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States
MD Anderson West Houston

Houston, Texas, 77079, United States
MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands

Conroe, Texas, 77384, United States
Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States
Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic Radiation Therapy-Northfield

Northfield, Minnesota, 55057, United States
Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States
McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States
McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States
McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867, United States
Memorial Hospital East

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

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

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

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

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

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

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

Harrison, New York, 10604, United States
Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital South

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

Springfield, Missouri, 65804, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States
New York Proton Center

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

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

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

Warrenville, Illinois, 60555, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Ridgeview Medical Center

Waconia, Minnesota, 55387, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States
UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Landerbrook Health Center

Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States
UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States
UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States
UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

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

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

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

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

Plantation, Florida, 33324, United States
UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States
UT MD Anderson - League City

League City, Texas, 77573, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
Unity Hospital

Fridley, Minnesota, 55432, United States
University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center

Ravenna, Ohio, 44266, United States
University Hospitals Sharon Health Center

Wadsworth, Ohio, 44281, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

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

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

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