Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Start Date
6/26/2019
Completion Date
12/21/2031
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.
Detailed Description
PRIMARY OBJECTIVES: I. To determine if overall survival (OS) is improved with proton beam radiation therapy (PBT) treatment as compared to intensity modulated photon radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer. II. To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT. SECONDARY OBJECTIVES: I. To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue. II. To compare the Quality-Adjusted Life Years (QALY) using EuroQol five-dimensional questionnaire (EQ5D) as a health outcome between PBT and IMRT, if the protocol primary endpoint is met. III. To assess the pathologic response rate between PBT and IMRT. IV. To assess the cost-benefit economic analysis of treatment between radiation modalities. V. To compare the length of hospitalization after protocol surgery between PBT and IMRT. VI. To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT. VII. To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT \& IMRT. VIII. To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT. IX. To compare incidence of both early (\< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT. X. To compare the total toxicity burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities. EXPLORATORY OBJECTIVES: I. To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive chemotherapy consisting of carboplatin/paclitaxel, or fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX)/capecitabine-oxaliplatin (CAPOX), or docetaxel/fluorouracil (5-FU, with capecitabine an acceptable substitute for 5-FU), as determined by the patient and their treating physician while undergoing PBT. GROUP II: Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive chemotherapy consisting of carboplatin/paclitaxel, or FOLFOX/CAPOX, or docetaxel/5-FU (with capecitabine an acceptable substitute for 5-FU) as determined by the patient and their treating physician while undergoing IMRT. In both groups, within 4-8 weeks after completion of chemotherapy and radiation therapy, patients should undergo an esophagectomy if it's determined that the patient can tolerate an esophagectomy and whether the tumor is surgically resectable. Additionally, patients undergo blood sample collection, and positron emission tomography (PET)/computed tomography (CT) or CT throughout the study. After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually thereafter.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Capecitabine
Carboplatin
Computed Tomography
Docetaxel
Esophagectomy
Fluorouracil
Intensity-Modulated Radiation Therapy
Leucovorin Calcium
Oxaliplatin
Paclitaxel
Positron Emission Tomography
Proton Beam Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Conditions
Locations
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Miami Cancer Institute
Miami, Florida 33176
United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
United States
Orlando Health Cancer Institute
Orlando, Florida 32806
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Emory Proton Therapy Center
Atlanta, Georgia 30308
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Alton Memorial Hospital
Alton, Illinois 62002
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
United States
Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United States
McLaren Cancer Institute-Flint
Flint, Michigan 48532
United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan 48858
United States
McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
United States
Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Unity Hospital
Fridley, Minnesota 55432
United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota 56001
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United States
Mayo Clinic Radiation Therapy-Northfield
Northfield, Minnesota 55057
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Ridgeview Medical Center
Waconia, Minnesota 55387
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
Mercy Hospital Springfield
Springfield, Missouri 65804
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Mercy Hospital South
St Louis, Missouri 63128
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
New York Proton Center
New York, New York 10035
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
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
Geauga Hospital
Chardon, Ohio 44024
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Case Western Reserve University
Cleveland, Ohio 44106
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Mercy Cancer Center-Elyria
Elyria, Ohio 44035
United States
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio 44124
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
United States
University Hospitals Parma Medical Center
Parma, Ohio 44129
United States
University Hospitals Portage Medical Center
Ravenna, Ohio 44266
United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
United States
University Hospitals Sharon Health Center
Wadsworth, Ohio 44281
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
United States
UHHS-Westlake Medical Center
Westlake, Ohio 44145
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
Covenant Health Proton Center
Knoxville, Tennessee 37909
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
MD Anderson in The Woodlands
Conroe, Texas 77384
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States
MD Anderson West Houston
Houston, Texas 77079
United States
UT MD Anderson - League City
League City, Texas 77573
United States
MD Anderson in Sugar Land
Sugar Land, Texas 77478
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Inova Alexandria Hospital
Alexandria, Virginia 22304
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Inova Fair Oaks Hospital
Fairfax, Virginia 22033
United States
Inova Loudoun Hospital
Leesburg, Virginia 20176
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin 54701
United States