Phase
Condition
Adenocarcinoma
Esophageal Disorders
Squamous Cell Carcinoma
Treatment
Proton Beam Radiation Therapy
Quality-of-Life Assessment
CAPOX regimen
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
PRIOR TO STEP 1 REGISTRATION:
Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of thethoracic esophagus or gastroesophageal junction (Siewert I-II)
Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
History/physical examination
Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) orchest/abdominal (include pelvic if clinically indicated) CT with contrast
For patients who DID NOT receive induction chemotherapy, scan must occurwithin 30 days prior to Step 1 registration
For patients who DID receive induction chemotherapy, scan must occur:
Within 30 days after final induction chemotherapy dose; OR
Within 30 days prior to Step 1 registration
Note: Patients who had prior endoscopic mucosal resection (EMR) with adiagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer areeligible
Surgical consultation to determine whether or not the patient is a candidate forresection after completion of chemoradiation
Induction chemotherapy for the current malignancy prior to concurrent chemoradiationallowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration. Only FOLFOX will be allowed as the induction chemotherapy regimen.
Zubrod performance status 0, 1, or 2
Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration)
For patients who DID NOT receive induction chemotherapy: ANC >= 1,500cells/mm^3
For patients who DID receive induction chemotherapy: ANC >= 1,000 cells/mm^3
Platelets (within 30 days prior to Step 1 registration)
For patients who DID NOT receive induction chemotherapy: Platelets >= 100,000/uL
For patients who DID receive induction chemotherapy: Platelets >= 75,000/uL
Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention toachieve Hgb >= 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration)
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance > 40mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1registration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 30 days prior to Step 1 registration)
Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registrationfor women of child bearing potential
The patient or a legally authorized representative must provide study-specificinformed consent prior to study entry
Exclusion
Exclusion Criteria:
Cervical esophageal cancers arisen from 15-18 cm from the incisors
Patients with T4b disease according to the AJCC 8th edition
Definitive clinical or radiologic evidence of metastatic disease
Any active malignancy within 2 years of study registration that may alter the courseof esophageal cancer treatment
Prior thoracic radiotherapy that would result in overlap of radiation therapy fields
Severe, active co-morbidity defined as follows:
Active uncontrolled infection requiring IV antibiotics at the time of Step 1registration
Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiacarrhythmia not controlled by any device or medication at the time of Step 1registration
Myocardial infarction within 3 months prior to Step 1 registration
Pregnant and/or nursing females
Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter.Note that patients who are HIV positive are eligible, provided they are undertreatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIVtesting is not required for eligibility for this protocol. This exclusion criterionis necessary because the treatments involved in this protocol may be significantlyimmunosuppressive
PRIOR TO STEP 2 REGISTRATION:
Unable to obtain confirmation of payment coverage (insurance or other) for eitherpossible radiation treatment
Study Design
Study Description
Connect with a study center
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United StatesActive - Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesActive - Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United StatesActive - Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United StatesActive - Recruiting
Miami Cancer Institute
Miami, Florida 33176
United StatesActive - Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesSite Not Available
Emory Proton Therapy Center
Atlanta, Georgia 30308
United StatesSite Not Available
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Emory University Hospital Midtown
Atlanta, Georgia 30308
United StatesSite Not Available
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Alton Memorial Hospital
Alton, Illinois 62002
United StatesActive - Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United StatesActive - Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United StatesActive - Recruiting
Memorial Hospital East
Shiloh, Illinois 62269
United StatesActive - Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United StatesActive - Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
United StatesActive - Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United StatesActive - Recruiting
McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
United StatesActive - Recruiting
Beaumont Hospital - Dearborn
Dearborn, Michigan 48124
United StatesActive - Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
United StatesActive - Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
McLaren Cancer Institute-Flint
Flint, Michigan 48532
United StatesActive - Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
United StatesActive - Recruiting
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
United StatesActive - Recruiting
McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
United StatesActive - Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
United StatesActive - Recruiting
William Beaumont Hospital - Troy
Troy, Michigan 48085
United StatesActive - Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
United StatesCompleted
Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesActive - Recruiting
Unity Hospital
Fridley, Minnesota 55432
United StatesSite Not Available
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota 56001
United StatesCompleted
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
United StatesActive - Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesActive - Recruiting
Mayo Clinic Radiation Therapy-Northfield
Northfield, Minnesota 55057
United StatesActive - Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Ridgeview Medical Center
Waconia, Minnesota 55387
United StatesActive - Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United StatesActive - Recruiting
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
United StatesActive - Recruiting
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
United StatesActive - Recruiting
Mercy Hospital Springfield
Springfield, Missouri 65804
United StatesActive - Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Commack
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
New York Proton Center
New York, New York 10035
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
United StatesActive - Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
United StatesActive - Recruiting
Geauga Hospital
Chardon, Ohio 44024
United StatesActive - Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Case Western Reserve University
Cleveland, Ohio 44106
United StatesActive - Recruiting
Mercy Cancer Center-Elyria
Elyria, Ohio 44035
United StatesSuspended
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio 44124
United StatesActive - Recruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
United StatesActive - Recruiting
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
United StatesActive - Recruiting
University Hospitals Parma Medical Center
Parma, Ohio 44129
United StatesActive - Recruiting
University Hospitals Portage Medical Center
Ravenna, Ohio 44266
United StatesActive - Recruiting
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
United StatesActive - Recruiting
University Hospitals Sharon Health Center
Wadsworth, Ohio 44281
United StatesActive - Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United StatesActive - Recruiting
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
United StatesSuspended
UHHS-Westlake Medical Center
Westlake, Ohio 44145
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Thompson Cancer Survival Center
Knoxville, Tennessee 37916
United StatesActive - Recruiting
Thompson Cancer Survival Center - West
Knoxville, Tennessee 37932
United StatesActive - Recruiting
Thompson Proton Center
Knoxville, Tennessee 37909
United StatesActive - Recruiting
Thompson Oncology Group-Maryville
Maryville, Tennessee 37804
United StatesSuspended
Thompson Oncology Group-Oak Ridge
Oak Ridge, Tennessee 37830
United StatesActive - Recruiting
MD Anderson in The Woodlands
Conroe, Texas 77384
United StatesActive - Recruiting
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
MD Anderson West Houston
Houston, Texas 77079
United StatesActive - Recruiting
MD Anderson League City
League City, Texas 77573
United StatesActive - Recruiting
MD Anderson in Sugar Land
Sugar Land, Texas 77478
United StatesActive - Recruiting
MD Anderson in The Woodlands
The Woodlands, Texas 77384
United StatesSite Not Available
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Inova Alexandria Hospital
Alexandria, Virginia 22304
United StatesSite Not Available
Inova Fair Oaks Hospital
Fairfax, Virginia 22033
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
Inova Loudoun Hospital
Leesburg, Virginia 20176
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin 54701
United StatesCompleted
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