Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03801876

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Led by NRG Oncology · Updated on 2026-05-07

300

Participants Needed

95

Research Sites

651 weeks

Total Duration

On this page

Sponsors

N

NRG Oncology

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)
  • Clinical stage I-IVA esophageal cancer, excluding T4b stage, based on AJCC 8th edition
  • Diagnostic evaluation including history, physical exam, and PET/CT or CT scans within specified timeframes
  • Surgical evaluation for potential tumor removal after chemoradiation
  • Induction chemotherapy allowed if completed 10 to 90 days before registration using approved regimens
  • Age 18 years or older
  • Zubrod performance status 0, 1, or 2
  • Adequate blood counts and organ function within 30 days prior to registration
  • Negative pregnancy test within 14 days prior to registration for women of childbearing potential
  • Signed informed consent prior to study entry
Not Eligible

You will not qualify if you...

  • Cervical esophageal cancers located 15-18 cm from incisors
  • T4b stage disease according to AJCC 8th edition
  • Evidence of metastatic disease
  • Active malignancy within 2 years that could affect esophageal cancer treatment
  • Prior chest radiation overlapping planned treatment fields
  • Severe active infections requiring IV antibiotics
  • Uncontrolled heart conditions or recent heart attack within 3 months
  • Pregnant or nursing females
  • HIV positive with CD4 count below 200 cells/microliter unless on treatment with adequate CD4 count
  • Inability to confirm insurance or payment coverage before treatment

AI-Screening

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Trial Site Locations

Total: 95 locations

1

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States, 85054

Active, Not Recruiting

2

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Active, Not Recruiting

3

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

4

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States, 33146

Actively Recruiting

5

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Actively Recruiting

6

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States, 33166

Actively Recruiting

7

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

8

Miami Cancer Institute

Miami, Florida, United States, 33176

Actively Recruiting

9

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States, 33176

Actively Recruiting

10

Orlando Health Cancer Institute

Orlando, Florida, United States, 32806

Active, Not Recruiting

11

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States, 33324

Actively Recruiting

12

Emory Proton Therapy Center

Atlanta, Georgia, United States, 30308

Active, Not Recruiting

13

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Active, Not Recruiting

14

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

15

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Active, Not Recruiting

16

Alton Memorial Hospital

Alton, Illinois, United States, 62002

Actively Recruiting

17

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States, 60115

Actively Recruiting

18

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States, 60134

Actively Recruiting

19

Memorial Hospital East

Shiloh, Illinois, United States, 62269

Actively Recruiting

20

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Actively Recruiting

21

Maryland Proton Treatment Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

22

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

23

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States, 21014

Active, Not Recruiting

24

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

25

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States, 48706

Actively Recruiting

26

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States, 48124

Actively Recruiting

27

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

28

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

29

McLaren Cancer Institute-Flint

Flint, Michigan, United States, 48532

Actively Recruiting

30

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States, 48910

Actively Recruiting

31

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States, 48446

Actively Recruiting

32

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States, 48867

Actively Recruiting

33

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

34

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States, 48085

Actively Recruiting

35

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States, 56007

Completed

36

Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

37

Unity Hospital

Fridley, Minnesota, United States, 55432

Active, Not Recruiting

38

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States, 56001

Completed

39

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States, 55109

Actively Recruiting

40

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

Actively Recruiting

41

Mayo Clinic Radiation Therapy-Northfield

Northfield, Minnesota, United States, 55057

Active, Not Recruiting

42

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

43

Ridgeview Medical Center

Waconia, Minnesota, United States, 55387

Actively Recruiting

44

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

45

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

46

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

Actively Recruiting

47

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

48

Mercy Hospital South

St Louis, Missouri, United States, 63128

Actively Recruiting

49

Siteman Cancer Center-South County

St Louis, Missouri, United States, 63129

Actively Recruiting

50

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States, 63136

Actively Recruiting

51

Mercy Hospital Saint Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

52

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

53

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

54

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

55

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Actively Recruiting

56

Memorial Sloan Kettering Westchester

East White Plains, New York, United States, 10604

Actively Recruiting

57

New York Proton Center

New York, New York, United States, 10035

Actively Recruiting

58

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

59

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Actively Recruiting

60

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States, 44011

Actively Recruiting

61

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States, 44122

Actively Recruiting

62

Geauga Hospital

Chardon, Ohio, United States, 44024

Actively Recruiting

63

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

64

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Actively Recruiting

65

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

66

Mercy Cancer Center-Elyria

Elyria, Ohio, United States, 44035

Suspended

67

UH Seidman Cancer Center at Landerbrook Health Center

Mayfield Heights, Ohio, United States, 44124

Suspended

68

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States, 44060

Actively Recruiting

69

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States, 44130

Actively Recruiting

70

University Hospitals Parma Medical Center

Parma, Ohio, United States, 44129

Actively Recruiting

71

University Hospitals Portage Medical Center

Ravenna, Ohio, United States, 44266

Actively Recruiting

72

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States, 44870

Actively Recruiting

73

University Hospitals Sharon Health Center

Wadsworth, Ohio, United States, 44281

Actively Recruiting

74

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States, 45069

Actively Recruiting

75

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States, 44145

Suspended

76

UHHS-Westlake Medical Center

Westlake, Ohio, United States, 44145

Actively Recruiting

77

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

78

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

79

Covenant Health Proton Center

Knoxville, Tennessee, United States, 37909

Actively Recruiting

80

Covenant Health Cancer Centers

Knoxville, Tennessee, United States, 37916

Actively Recruiting

81

Covenant Health Cancer Centers - West

Knoxville, Tennessee, United States, 37932

Actively Recruiting

82

Covenant Health Oncology Group - Maryville

Maryville, Tennessee, United States, 37804

Suspended

83

Covenant Health Oncology Group - Oak Ridge

Oak Ridge, Tennessee, United States, 37830

Actively Recruiting

84

MD Anderson in The Woodlands

Conroe, Texas, United States, 77384

Actively Recruiting

85

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

86

MD Anderson West Houston

Houston, Texas, United States, 77079

Actively Recruiting

87

MD Anderson League City

League City, Texas, United States, 77573

Actively Recruiting

88

MD Anderson in Sugar Land

Sugar Land, Texas, United States, 77478

Actively Recruiting

89

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

90

Inova Alexandria Hospital

Alexandria, Virginia, United States, 22304

Active, Not Recruiting

91

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Active, Not Recruiting

92

Inova Fair Oaks Hospital

Fairfax, Virginia, United States, 22033

Active, Not Recruiting

93

Inova Loudoun Hospital

Leesburg, Virginia, United States, 20176

Active, Not Recruiting

94

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Active, Not Recruiting

95

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States, 54701

Completed

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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