Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 15, 2019

Primary Completion Date

December 21, 2026

Study Completion Date

December 21, 2031

Conditions
Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Thoracic Esophagus Squamous Cell Carcinoma
Interventions
DRUG

Carboplatin

Given IV

PROCEDURE

Esophagectomy

Undergo esophagectomy

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Paclitaxel

Given IV

RADIATION

Proton Beam Radiation Therapy

Undergo PBT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

FOLFOX regimen

Folinic acid, flurouracil and oxaliplatin

DRUG

CAPOX regimen

Capecitabine combined with oxaliplatin

DRUG

Docetaxel

Chemotherapy

DRUG

5FU

Chemotherapy

Trial Locations (90)

10035

RECRUITING

New York Proton Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack, Commack

19104

RECRUITING

University of Pennsylvania/Abramson Cancer Center, Philadelphia

20176

ACTIVE_NOT_RECRUITING

Inova Loudoun Hospital, Leesburg

21014

RECRUITING

UM Upper Chesapeake Medical Center, Bel Air

21201

RECRUITING

Maryland Proton Treatment Center, Baltimore

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

22031

ACTIVE_NOT_RECRUITING

Inova Schar Cancer Institute, Fairfax

22033

ACTIVE_NOT_RECRUITING

Inova Fair Oaks Hospital, Fairfax

22304

ACTIVE_NOT_RECRUITING

Inova Alexandria Hospital, Alexandria

30308

ACTIVE_NOT_RECRUITING

Emory Proton Therapy Center, Atlanta

ACTIVE_NOT_RECRUITING

Emory University Hospital Midtown, Atlanta

30322

ACTIVE_NOT_RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

ACTIVE_NOT_RECRUITING

Emory Saint Joseph's Hospital, Atlanta

32806

ACTIVE_NOT_RECRUITING

Orlando Health Cancer Institute, Orlando

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33176

RECRUITING

Miami Cancer Institute, Miami

33442

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

37804

SUSPENDED

Thompson Oncology Group-Maryville, Maryville

37830

RECRUITING

Thompson Oncology Group-Oak Ridge, Oak Ridge

37909

RECRUITING

Thompson Proton Center, Knoxville

37916

RECRUITING

Thompson Cancer Survival Center, Knoxville

37932

RECRUITING

Thompson Cancer Survival Center - West, Knoxville

44011

RECRUITING

UH Seidman Cancer Center at UH Avon Health Center, Avon

44024

RECRUITING

Geauga Hospital, Chardon

44035

SUSPENDED

Mercy Cancer Center-Elyria, Elyria

44060

RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

RECRUITING

Case Western Reserve University, Cleveland

44122

RECRUITING

UHHS-Chagrin Highlands Medical Center, Beachwood

44124

RECRUITING

UH Seidman Cancer Center at Landerbrook Health Center, Mayfield Heights

44129

RECRUITING

University Hospitals Parma Medical Center, Parma

44130

RECRUITING

UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights

44145

SUSPENDED

UH Seidman Cancer Center at Saint John Medical Center, Westlake

RECRUITING

UHHS-Westlake Medical Center, Westlake

44266

RECRUITING

University Hospitals Portage Medical Center, Ravenna

44281

RECRUITING

University Hospitals Sharon Health Center, Wadsworth

44870

RECRUITING

UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

48073

RECRUITING

Corewell Health William Beaumont University Hospital, Royal Oak

48085

RECRUITING

Corewell Health Beaumont Troy Hospital, Troy

48124

RECRUITING

Corewell Health Dearborn Hospital, Dearborn

48201

RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48334

RECRUITING

Weisberg Cancer Treatment Center, Farmington Hills

48446

RECRUITING

McLaren Cancer Institute-Lapeer Region, Lapeer

48532

RECRUITING

McLaren Cancer Institute-Flint, Flint

48706

RECRUITING

McLaren Cancer Institute-Bay City, Bay City

48867

RECRUITING

McLaren Cancer Institute-Owosso, Owosso

48910

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing, Lansing

54701

COMPLETED

Mayo Clinic Health System-Eau Claire Clinic, Eau Claire

55057

RECRUITING

Mayo Clinic Radiation Therapy-Northfield, Northfield

55109

RECRUITING

Minnesota Oncology Hematology PA-Maplewood, Maplewood

55387

RECRUITING

Ridgeview Medical Center, Waconia

55415

RECRUITING

Hennepin County Medical Center, Minneapolis

55432

ACTIVE_NOT_RECRUITING

Unity Hospital, Fridley

55433

RECRUITING

Mercy Hospital, Coon Rapids

55905

ACTIVE_NOT_RECRUITING

Mayo Clinic in Rochester, Rochester

56001

COMPLETED

Mayo Clinic Health Systems-Mankato, Mankato

56007

COMPLETED

Mayo Clinic Health System in Albert Lea, Albert Lea

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

62002

RECRUITING

Alton Memorial Hospital, Alton

62269

RECRUITING

Memorial Hospital East, Shiloh

63110

RECRUITING

Washington University School of Medicine, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

RECRUITING

Mercy Hospital Saint Louis, St Louis

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

65804

RECRUITING

Mercy Hospital Springfield, Springfield

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

77030

RECRUITING

M D Anderson Cancer Center, Houston

77079

RECRUITING

MD Anderson West Houston, Houston

77384

RECRUITING

MD Anderson in The Woodlands, Conroe

77478

RECRUITING

MD Anderson in Sugar Land, Sugar Land

77573

RECRUITING

MD Anderson League City, League City

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

85054

RECRUITING

Mayo Clinic Hospital in Arizona, Phoenix

85259

ACTIVE_NOT_RECRUITING

Mayo Clinic in Arizona, Scottsdale

98195

ACTIVE_NOT_RECRUITING

University of Washington Medical Center - Montlake, Seattle

02114

RECRUITING

Massachusetts General Hospital Cancer Center, Boston

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen, Montvale

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER

NCT03801876 - Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer | Biotech Hunter | Biotech Hunter