National indication protocol for proton radiotherapy in esophageal cancer patients in the Netherlands.
Christina T Muijs, Yvonne L B Klaver, Joost Nuyttens...
https://pubmed.ncbi.nlm.nih.gov/41005671Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID03801876
Phase III Randomized Trial Comparing Proton Beam Therapy and Intensity Modulated Photon Radiotherapy for Esophageal Cancer
Led by NRG Oncology · Updated on 2026-05-07
300
Participants Needed
95
Research Sites
260 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
Researchers are evaluating how well proton beam radiation therapy compares to intensity modulated photon radiotherapy in treating patients with stage I-IVA esophageal cancer. This phase III trial aims to determine whether proton beam therapy improves overall survival and reduces serious heart and lung side effects compared to photon radiotherapy. The study also examines symptom burden, quality of life, treatment costs, and disease control outcomes. Participants are randomly assigned to one of two treatment groups. One group receives proton beam therapy over 28 sessions in 5.5 weeks alongside chemotherapy with drugs like carboplatin, paclitaxel, or fluorouracil-based regimens. The other group receives intensity modulated photon radiotherapy on the same schedule with similar chemotherapy options. Both groups undergo blood sample collection and imaging scans such as PET/CT or CT during treatment. Surgery to remove the esophagus is considered within 4 to 8 weeks after therapy if feasible. Throughout the study, participants will have follow-up visits every 3 to 6 months for three years, then annually afterward. Researchers will monitor survival, heart and lung toxicities, immune cell counts, symptom changes, hospital stays, and cancer progression. Patient-reported outcomes and quality-of-life measures are collected, along with biospecimens for future biomarker analysis. This comprehensive monitoring will help assess the benefits and risks of each radiation approach over time.
CONDITIONS
Brief Title
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
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 to IVA esophageal cancer excluding T4b disease
- Age 18 years or older
- Zubrod performance status of 0, 1, or 2
- Adequate blood counts and organ function within 30 days before registration
- Surgical consultation completed to assess esophagectomy candidacy
- Induction chemotherapy allowed if completed 10 to 90 days prior to registration with approved regimens
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
- Informed consent provided by patient or legally authorized representative
You will not qualify if you...
- Cervical esophageal cancers located 15-18 cm from the incisors
- T4b esophageal cancer
- Evidence of metastatic disease
- Active malignancy within 2 years that may affect esophageal cancer treatment
- Prior thoracic radiation overlapping planned treatment fields
- Severe active infections requiring IV antibiotics
- Uncontrolled heart failure, unstable angina, or cardiac arrhythmias
- Myocardial infarction within 3 months prior to registration
- Pregnant or nursing females
- HIV positive with CD4 count below 200 cells/microliter unless on treatment with adequate CD4 count
- Unable to confirm payment coverage for radiation treatment prior to step 2 registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5.5 weeks
Participants undergo proton beam therapy or intensity modulated photon radiation therapy concurrent with chemotherapy over approximately 5.5 weeks. During this period, participants also have blood sample collections and PET/CT or CT scans as part of the study procedures.
Daily visits 5 days a week for radiation therapy over 5.5 weeks; blood sample collection and imaging visits throughout treatment
Surgery
Duration - 1 day for surgery plus immediate recovery
Within 4 to 8 weeks after completing chemoradiation, participants who are eligible undergo esophagectomy surgery.
1 surgery visit and immediate post-operative care
Post-operative Follow-up
Duration - Several weeks following surgery
Participants are monitored for recovery and any complications following surgery.
Approximately 6 post-operative visits
Follow-up
Duration - Up to 8 years
Participants are followed up every 3 to 6 months for 3 years and annually thereafter to monitor health status, survival, and any long-term effects of treatment.
Follow-up visits every 3 to 6 months for 3 years, then annually
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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