Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Purpose

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

  • Clinical Stage I Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Thoracic Esophagus Squamous Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION: - Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic 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) or chest/abdominal (include pelvic if clinically indicated) CT with contrast - For patients who DID NOT receive induction chemotherapy, scan must occur within 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 a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible - Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation - Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed 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 >= 1,500 cells/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 to achieve 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 > 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration) - 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 registration for women of child bearing potential - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

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 course of 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 1 registration - Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration - 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 under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive - PRIOR TO STEP 2 REGISTRATION: - Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (PBT, Chemotherapy, Esophagectomy) 		Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing PBT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Esophagectomy
    Undergo esophagectomy
    Other names:
    • excision of the esophagus
  • Drug: Paclitaxel
    Given IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Radiation: Proton Beam Radiation Therapy
    Undergo PBT
    Other names:
    • PBRT
    • Proton Radiation Therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: FOLFOX regimen
    Folinic acid, flurouracil and oxaliplatin
    Other names:
    • FOLFOX
  • Drug: CAPOX regimen
    Capecitabine combined with oxaliplatin
    Other names:
    • CAPE-OX
    • OxCap
  • Drug: Docetaxel
    Chemotherapy
    Other names:
    • Taxotere
  • Drug: 5FU
    Chemotherapy
    Other names:
    • 5-FU
    • flurouracil
    • Tolak
    • Fluoroplex
    • Efudex
    • Carac
    • Adrucil
Active Comparator
Group II (IMRT, Chemotherapy, Esophagectomy) 		Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing IMRT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Esophagectomy
    Undergo esophagectomy
    Other names:
    • excision of the esophagus
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
  • Drug: Paclitaxel
    Given IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: FOLFOX regimen
    Folinic acid, flurouracil and oxaliplatin
    Other names:
    • FOLFOX
  • Drug: CAPOX regimen
    Capecitabine combined with oxaliplatin
    Other names:
    • CAPE-OX
    • OxCap
  • Drug: Docetaxel
    Chemotherapy
    Other names:
    • Taxotere
  • Drug: 5FU
    Chemotherapy
    Other names:
    • 5-FU
    • flurouracil
    • Tolak
    • Fluoroplex
    • Efudex
    • Carac
    • Adrucil

Recruiting Locations

Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

Miami Cancer Institute
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Maryland Proton Treatment Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
410-369-5226
info@mdproton.com

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Site Public Contact
877-726-5130

McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
Contact:
Site Public Contact
248-551-7695

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Flint
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
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Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
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313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
Contact:
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313-576-9790
ctoadmin@karmanos.org

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mayo Clinic Radiation Therapy-Northfield
Northfield, Minnesota 55057
Contact:
Site Public Contact
855-776-0015

Ridgeview Medical Center
Waconia, Minnesota 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Contact:
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800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
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212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
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212-639-7592

Memorial Sloan Kettering Commack
Commack, New York 11725
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Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

New York Proton Center
New York, New York 10035
Contact:
Site Public Contact
646-968-9031
ichoi@nyproton.com

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Contact:
Site Public Contact
800-641-2422

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Geauga Hospital
Chardon, Ohio 44024
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

University Hospitals Parma Medical Center
Parma, Ohio 44129
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

University Hospitals Portage Medical Center
Ravenna, Ohio 44266
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

University Hospitals Sharon Health Center
Wadsworth, Ohio 44281
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

UHHS-Westlake Medical Center
Westlake, Ohio 44145
Contact:
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800-641-2422
CTUReferral@UHhospitals.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Contact:
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855-216-0098
PennCancerTrials@careboxhealth.com

Thompson Proton Center
Knoxville, Tennessee 37909
Contact:
Site Public Contact
865-531-5118
jwilso31@covhlth.com

Thompson Cancer Survival Center
Knoxville, Tennessee 37916
Contact:
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865-331-1812

Thompson Cancer Survival Center - West
Knoxville, Tennessee 37932
Contact:
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865-331-1812

Thompson Oncology Group-Maryville
Maryville, Tennessee 37804
Contact:
Site Public Contact
865-331-1812

Thompson Oncology Group-Oak Ridge
Oak Ridge, Tennessee 37830
Contact:
Site Public Contact
865-331-1812

MD Anderson in The Woodlands
Conroe, Texas 77384
Contact:
Site Public Contact
866-632-6789
askmdanderson@mdanderson.org

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson West Houston
Houston, Texas 77079
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson League City
League City, Texas 77573
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Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson in Sugar Land
Sugar Land, Texas 77478
Contact:
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877-632-6789
askmdanderson@mdanderson.org

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

More Details

NCT ID
NCT03801876
Status
Recruiting
Sponsor
NRG Oncology

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 paclitaxel intravenously (IV) and carboplatin IV on days 1, 8, 15, 22, 29, and 36 while undergoing PBT. GROUP II: Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV and carboplatin IV on days 1, 8, 15, 22, 29, and 36 while undergoing IMRT. In both groups, within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion. After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually thereafter.