RecruitingPhase 3NCT03801876

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer


Sponsor

NRG Oncology

Enrollment

300 participants

Start Date

Jun 26, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy for esophageal cancer (cancer of the food pipe): proton therapy (a newer, more targeted form of radiation) versus standard photon radiation (traditional X-ray-based radiation). Both are delivered alongside chemotherapy. Researchers want to know if proton therapy causes fewer side effects while being equally effective. **You may be eligible if...** - You have been diagnosed with adenocarcinoma or squamous cell carcinoma (the two main types of esophageal cancer) confirmed by biopsy - Your cancer is in the chest area of the esophagus or the junction between the esophagus and stomach - Your cancer is stage I through IVA (not the most advanced stage) - You are able to undergo radiation and chemotherapy **You may NOT be eligible if...** - Your cancer is stage T4b (has grown into nearby structures like the heart or large blood vessels) - You have received prior radiation to the chest - You have conditions that prevent safe delivery of the study treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCapecitabine

Oral

DRUGCarboplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGDocetaxel

IV

PROCEDUREEsophagectomy

Undergo esophagectomy

DRUGFluorouracil

IV

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

DRUGLeucovorin Calcium

Oral

DRUGOxaliplatin

IV

DRUGPaclitaxel

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONProton Beam Radiation Therapy

Undergo PBT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(95)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Alton Memorial Hospital

Alton, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic Radiation Therapy-Northfield

Northfield, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

New York Proton Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Geauga Hospital

Chardon, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

UH Seidman Cancer Center at Landerbrook Health Center

Mayfield Heights, Ohio, United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

University Hospitals Parma Medical Center

Parma, Ohio, United States

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

University Hospitals Sharon Health Center

Wadsworth, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States

UHHS-Westlake Medical Center

Westlake, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Covenant Health Proton Center

Knoxville, Tennessee, United States

Covenant Health Cancer Centers

Knoxville, Tennessee, United States

Covenant Health Cancer Centers - West

Knoxville, Tennessee, United States

Covenant Health Oncology Group - Maryville

Maryville, Tennessee, United States

Covenant Health Oncology Group - Oak Ridge

Oak Ridge, Tennessee, United States

MD Anderson in The Woodlands

Conroe, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Inova Alexandria Hospital

Alexandria, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Inova Loudoun Hospital

Leesburg, Virginia, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

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NCT03801876


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