Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

August 16, 2023 updated by: National Cancer Institute (NCI)

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

l. To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with human epidermal growth factor receptor 2 (HER2)-overexpressing esophageal adenocarcinoma.

SECONDARY OBJECTIVES:

I. To evaluate if the addition of trastuzumab to trimodality treatment increases the pathologic complete response rate and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma.

II. To develop a tissue bank of tumor tissue from patients with non-metastatic esophageal adenocarcinoma.

III. To determine molecular correlates of complete pathologic response, disease-free survival, and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma treated with neoadjuvant and maintenance trastuzumab.

IV. To evaluate predictors of cardiotoxicity in patients with esophageal cancer treated with trastuzumab and chemoradiation.

V. To evaluate adverse events associated with the addition of trastuzumab to trimodality treatment for patients with non-metastatic esophageal adenocarcinoma.

PATIENT-REPORTED QUALITY OF LIFE OBJECTIVES:

I. To determine if the addition of trastuzumab to trimodality treatment improves the patient-reported Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) Esophageal Cancer Subscale (ECS) score.

II. To determine if an improvement in the FACT-E ECS score at 6-8 weeks post completion of neoadjuvant chemoradiation correlates with pathologic complete response.

III. To determine if pathologic complete response correlates with the FACT-E ECS score at 1 year and/or 2 years from the start of chemoradiation.

IV. To determine if the addition of trastuzumab to trimodality treatment improves the Swallow Index and Eating Index Subscale scores of the FACT-E.

V. To determine if the addition of trastuzumab to paclitaxel, carboplatin, and radiation impacts quality-adjusted survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive trastuzumab intravenously (IV) over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57 and paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Within 5-8 weeks after completion of radiotherapy, all patients undergo surgery.

After completion of study therapy, patients are followed up every 4 months for 2 years and then yearly thereafter.

Study Type

Interventional

Enrollment (Actual)

203

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Birmingham, Alabama, United States, 35243
    - The Kirklin Clinic at Acton Road
  - Mobile, Alabama, United States, 36608
    - Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital in Arizona
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
  - Tucson, Arizona, United States, 85719
    - Banner University Medical Center - Tucson
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Auburn, California, United States, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Burlingame, California, United States, 94010
    - Mills-Peninsula Medical Center
  - Cameron Park, California, United States, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Carmichael, California, United States, 95608
    - Mercy San Juan Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Chico, California, United States, 95926
    - Enloe Medical Center
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Dublin, California, United States, 94568
    - Epic Care-Dublin
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Emeryville, California, United States, 94608
    - Epic Care Partners in Cancer Care
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente-Fresno
  - Fresno, California, United States, 93720
    - Fresno Cancer Center
  - Greenbrae, California, United States, 94904
    - Marin General Hospital
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland-Broadway
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Palo Alto, California, United States, 94304
    - Stanford Cancer Institute Palo Alto
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Rancho Cordova, California, United States, 95670
    - Kaiser Permanente-Rancho Cordova Cancer Center
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Rohnert Park, California, United States, 94928
    - Rohnert Park Cancer Center
  - Roseville, California, United States, 95678
    - The Permanente Medical Group-Roseville Radiation Oncology
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95823
    - South Sacramento Cancer Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - Saint Helena, California, United States, 94574
    - Saint Helena Hospital
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Cancer Treatment Center
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vacaville, California, United States, 95687
    - Sutter Cancer Centers Radiation Oncology Services-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80222
    - Western States Cancer Research NCORP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Englewood, Colorado, United States, 80113
    - Mountain Blue Cancer Care Center - Swedish
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Meriden, Connecticut, United States, 06451
    - Midstate Medical Center
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology and Oncology Associates
  - Norwich, Connecticut, United States, 06360
    - William Backus Hospital
- Delaware
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - AdventHealth Altamonte
  - Kissimmee, Florida, United States, 34744
    - AdventHealth Kissimmee
  - Miami, Florida, United States, 33176
    - Miami Cancer Institute
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32822
    - AdventHealth East Orlando
  - Stuart, Florida, United States, 34994
    - Robert and Carol Weissman Cancer Center at Martin Health
  - Winter Park, Florida, United States, 32792
    - AdventHealth Winter Park
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, United States, 30303
    - Grady Health System
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center-Gainesville
  - Macon, Georgia, United States, 31201
    - Medical Center of Central Georgia
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Lewiston, Idaho, United States, 83501
    - Saint Joseph Regional Medical Center
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Berwyn, Illinois, United States, 60402
    - Mac Neal Hospital
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Oak Lawn, Illinois, United States, 60453-2699
    - Advocate Christ Medical Center
  - River Forest, Illinois, United States, 60305
    - West Suburban Medical Center
  - Rockford, Illinois, United States, 61114
    - SwedishAmerican Regional Cancer Center/ACT
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - Franciscan Saint Francis Health-Beech Grove
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46805
    - Parkview Hospital Randallia
  - Fort Wayne, Indiana, United States, 46804
    - Radiation Oncology Associates PC
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Health Indianapolis
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Muncie, Indiana, United States, 47303
    - IU Health Ball Memorial Hospital
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic - Ames
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Boone, Iowa, United States, 50036
    - McFarland Clinic - Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic - Marshalltown
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center-Sioux City
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, United States, 66112
    - University of Kansas Cancer Center-West
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Prairie Village, Kansas, United States, 66208
    - Kansas City NCI Community Oncology Research Program
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
- Maine
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
  - Portland, Maine, United States, 04102
    - Maine Medical Center-Bramhall Campus
  - Scarborough, Maine, United States, 04074
    - Maine Medical Center- Scarborough Campus
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Bel Air, Maryland, United States, 21014
    - UM Upper Chesapeake Medical Center
  - Salisbury, Maryland, United States, 21801
    - TidalHealth Peninsula Regional
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
  - Milford, Massachusetts, United States, 01757
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Medical Center - Cancer Center
  - South Weymouth, Massachusetts, United States, 02190
    - Dana-Farber/Brigham and Women's Cancer Center at South Shore
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
  - Springfield, Massachusetts, United States, 01107
    - D'Amour Center for Cancer Care
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital - Dearborn
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Novi, Michigan, United States, 48374
    - Ascension Providence Hospitals - Novi
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Southfield, Michigan, United States, 48075
    - Ascension Providence Hospitals - Southfield
  - Troy, Michigan, United States, 48085
    - William Beaumont Hospital - Troy
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64131
    - The University of Kansas Cancer Center-South
  - Kansas City, Missouri, United States, 64111
    - Saint Luke'S Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - CHI Health Saint Francis
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - GenesisCare USA - Henderson
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89109
    - GenesisCare USA - Las Vegas
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - GenesisCare USA - Vegas Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89148
    - GenesisCare USA - Fort Apache
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89169
    - Nevada Cancer Research Foundation NCORP
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - Concord Hospital
  - Dover, New Hampshire, United States, 03820
    - Wentworth-Douglass Hospital
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Basking Ridge
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Morristown, New Jersey, United States, 07960
    - Morristown Medical Center
  - Mount Holly, New Jersey, United States, 08060
    - Virtua Memorial
  - Newark, New Jersey, United States, 07101
    - Rutgers New Jersey Medical School
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Pennington, New Jersey, United States, 08534
    - Capital Health Medical Center-Hopewell
  - Sparta, New Jersey, United States, 07871
    - Sparta Cancer Treatment Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Voorhees, New Jersey, United States, 08043
    - Virtua Voorhees
  - Voorhees, New Jersey, United States, 08043
    - MD Anderson Cancer Center at Cooper-Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
  - Canandaigua, New York, United States, 14424
    - Sands Cancer Center
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Commack
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering Westchester
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10019
    - Mount Sinai West
  - New York, New York, United States, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, United States, 10003
    - Mount Sinai Union Square
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rochester, New York, United States, 14606
    - Wilmot Cancer Institute Radiation Oncology at Greece
  - Sleepy Hollow, New York, United States, 10591
    - Memorial Sloan Kettering Sleepy Hollow
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Nassau
- North Carolina
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Charlotte, North Carolina, United States, 28210
    - Atrium Health Pineville/LCI-Pineville
  - Concord, North Carolina, United States, 28025
    - Atrium Health Cabarrus/LCI-Concord
  - Kinston, North Carolina, United States, 28501
    - Vidant Oncology-Kinston
  - Matthews, North Carolina, United States, 28105
    - Matthews Radiation Oncology Center
  - Monroe, North Carolina, United States, 28112
    - Atrium Health Union/LCI-Union
  - Raleigh, North Carolina, United States, 27607
    - UNC Rex Healthcare
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Akron, Ohio, United States, 44304
    - Summa Health System - Akron Campus
  - Barberton, Ohio, United States, 44203
    - Summa Health System - Barberton Campus
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chardon, Ohio, United States, 44024
    - Geauga Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc-Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45459
    - Dayton NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Medina, Ohio, United States, 44256
    - Summa Health Medina Medical Center
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Middleburg Heights, Ohio, United States, 44130
    - UH Seidman Cancer Center at Southwest General Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Parma, Ohio, United States, 44129
    - University Hospitals Parma Medical Center
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Ravenna, Ohio, United States, 44266
    - University Hospitals Portage Medical Center
  - Salem, Ohio, United States, 44460
    - UH Seidman Cancer Center at Salem Regional Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Sandusky, Ohio, United States, 44870
    - UH Seidman Cancer Center at Firelands Regional Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Mercy Health - Saint Anne Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - West Chester, Ohio, United States, 45069
    - University of Cincinnati Cancer Center-West Chester
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Wooster, Ohio, United States, 44691
    - Cancer Treatment Center
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Salem, Oregon, United States, 97301
    - Salem Hospital
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - UPMC-Heritage Valley Health System Beaver
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - Dunmore, Pennsylvania, United States, 18512
    - Northeast Radiation Oncology Center
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Moon, Pennsylvania, United States, 15108
    - UPMC Hillman Cancer Center in Coraopolis
  - Natrona Heights, Pennsylvania, United States, 15065
    - Allegheny Valley Hospital
  - Natrona Heights, Pennsylvania, United States, 15065
    - UPMC Cancer Center-Natrona Heights
  - New Castle, Pennsylvania, United States, 16105
    - UPMC Jameson
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19114
    - Jefferson Torresdale Hospital
  - Philadelphia, Pennsylvania, United States, 19103
    - American College of Radiology Imaging Network
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC-Shadyside Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Presbyterian Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15236
    - UPMC Jefferson Regional Radiation Oncology
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Seneca, Pennsylvania, United States, 16346
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Uniontown Hospital Radiation Oncology
  - Washington, Pennsylvania, United States, 15301
    - UPMC Washington Hospital Radiation Oncology
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, United States, 15090
    - Wexford Health and Wellness Pavilion
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Main Line Health NCORP
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
  - Providence, Rhode Island, United States, 02906
    - Miriam Hospital
  - Providence, Rhode Island, United States, 02904
    - Radiation Oncology Associates Incorporated
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29601
    - Greenville Health System Cancer Institute-Andrews
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Rock Hill, South Carolina, United States, 29730
    - Rock Hill Radiation Therapy Center
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - League City, Texas, United States, 77573
    - UTMB Cancer Center at Victory Lakes
  - Lubbock, Texas, United States, 79410
    - Covenant Medical Center-Lakeside
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84107
    - Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center
  - Saint George, Utah, United States, 84770
    - Saint George Regional Medical Center
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
- Vermont
  - Saint Johnsbury, Vermont, United States, 05819
    - Norris Cotton Cancer Center-North
- Virginia
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional Cancer Center
- Washington
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Auburn, Washington, United States, 98001
    - MultiCare Auburn Medical Center
  - Bellevue, Washington, United States, 98004
    - Overlake Medical Center
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Bremerton, Washington, United States, 98310
    - Harrison Medical Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Olympia, Washington, United States, 98506-5166
    - Providence - Saint Peter Hospital
  - Olympia, Washington, United States, 98507
    - Capital Medical Center
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Puyallup, Washington, United States, 98372
    - MultiCare Good Samaritan Hospital
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center - Montlake
  - Seattle, Washington, United States, 98109
    - FHCC South Lake Union
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Sequim, Washington, United States, 98384
    - Olympic Medical Cancer Care Center
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology PS
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - MultiCare Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - Northwest NCI Community Oncology Research Program
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston Division
  - Wheeling, West Virginia, United States, 26003
    - Wheeling Hospital/Schiffler Cancer Center
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Eau Claire, Wisconsin, United States, 54701
    - HSHS Sacred Heart Hospital
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Zablocki Veterans Administration Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Rhinelander, Wisconsin, United States, 54501
    - Ascension Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Stevens Point, Wisconsin, United States, 54481
    - Ascension Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - Aurora Cancer Care-Waukesha
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - West Bend, Wisconsin, United States, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach up to 5 cm
Endoscopy with biopsy
PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
Intent to submit tissue for central HER2 testing
Stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based on the following minimum diagnostic work-up:
- Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body PET/CT will be required prior to step 2 registration; PET/CT of skull base to mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT scan, an endoscopic ultrasound is not required prior to STEP 2 registration as long as adequate tissue has been obtained for central HER2 testing)
- Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2 cm
- Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
Zubrod performance status 0-2
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
Platelets >= 100,000 cells/mm^3
Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
Creatinine =< 2 times upper limit of normal
Bilirubin =< 1.5 times upper limit of normal
Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal
For women of childbearing potential, a negative serum or urine pregnancy test
Patients must sign a study-specific informed consent prior to study entry
CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)
HER2 expressing adenocarcinoma of the esophagus centrally
Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to step 2 registration
Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to step 2 registration
Consultation with a medical oncologist within 56 days prior to step 2 registration
Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:
- History/physical examination, with documentation of the patient's weight, within 14 days prior to step 2 registration
- Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)
- Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan
- Electrocardiogram (EKG) within 56 days prior to step 2 registration
- Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registration
Zubrod performance status 0-2 within 14 days prior to step 2 registration
For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration
Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by cardiac echocardiogram (echo) or multi gated acquisition (MUGA) scan within 56 days prior to step 2 registration
Women of childbearing potential and sexually active male participants must agree to practice adequate contraception while on study and for at least 60 days following the last dose of chemotherapy or trastuzumab

Exclusion Criteria:

Patients with cervical esophageal carcinoma
Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)
Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiation therapy for esophageal cancer or prior chest radiotherapy
Prior anthracycline or taxane
Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)
Medical contraindications to esophagectomy
Prior therapy with any agent targeting the HER2 pathway or human epidermal growth factor receptor 1 (HER1) (epidermal growth factor receptor [EGFR]) pathway
Prior therapy with trastuzumab
Prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody
Previous history of congestive heart failure
Severe, active comorbidity, defined as follows:
- Unstable angina in the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immunocompromised patients
Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (radiotherapy, chemotherapy, trastuzumab) Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57 and paclitaxel intravenously IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Biological: Trastuzumab Given IV Other Names: Herceptin ABP 980 ALT02 Herceptin Biosimilar PF-05280014 Herceptin Trastuzumab Biosimilar PF-05280014 Herzuma Ogivri Ontruzant PF-05280014 rhuMAb HER2 RO0452317 SB3 Trastuzumab Biosimilar ABP 980 Trastuzumab Biosimilar ALT02 trastuzumab biosimilar EG12014 Trastuzumab Biosimilar HLX02 Trastuzumab Biosimilar PF-05280014 Trastuzumab Biosimilar SB3 Trastuzumab-dkst Trastuzumab-dttb Trastuzumab-pkrb Trazimera Kanjinti Trastuzumab Biosimilar SIBP-01 Trastuzumab-anns Trastuzumab-qyyp QL 1701 QL-1701 QL1701 Trastuzumab Biosimilar QL1701 CT-P06 CT-P6 Trastuzumab Biosimilar CT-P6 Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Procedure: Therapeutic Conventional Surgery Undergo surgery Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Energy Type
Experimental: Arm II (radiotherapy and chemotherapy) Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Procedure: Therapeutic Conventional Surgery Undergo surgery Radiation: Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Energy Type

Participant Group / Arm

Intervention / Treatment

Experimental: Arm I (radiotherapy, chemotherapy, trastuzumab)

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57 and paclitaxel intravenously IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis

Correlative studies

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Biological: Trastuzumab

Given IV

Other Names:

Herceptin
ABP 980
ALT02
Herceptin Biosimilar PF-05280014
Herceptin Trastuzumab Biosimilar PF-05280014
Herzuma
Ogivri
Ontruzant
PF-05280014
rhuMAb HER2
RO0452317
SB3
Trastuzumab Biosimilar ABP 980
Trastuzumab Biosimilar ALT02
trastuzumab biosimilar EG12014
Trastuzumab Biosimilar HLX02
Trastuzumab Biosimilar PF-05280014
Trastuzumab Biosimilar SB3
Trastuzumab-dkst
Trastuzumab-dttb
Trastuzumab-pkrb
Trazimera
Kanjinti
Trastuzumab Biosimilar SIBP-01
Trastuzumab-anns
Trastuzumab-qyyp
QL 1701
QL-1701
QL1701
Trastuzumab Biosimilar QL1701
CT-P06
CT-P6
Trastuzumab Biosimilar CT-P6

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Procedure: Therapeutic Conventional Surgery

Undergo surgery

Radiation: Radiation Therapy

Undergo radiation therapy

Other Names:

Cancer Radiotherapy
ENERGY_TYPE
Irradiate
Irradiated
Irradiation
Radiation
Radiation Therapy, NOS
Radiotherapeutics
Radiotherapy
RT
Therapy, Radiation
Energy Type

Experimental: Arm II (radiotherapy and chemotherapy)

Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Other: Laboratory Biomarker Analysis

Correlative studies

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Drug: Paclitaxel

Given IV

Other Names:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Procedure: Therapeutic Conventional Surgery

Undergo surgery

Radiation: Radiation Therapy

Undergo radiation therapy

Other Names:

Cancer Radiotherapy
ENERGY_TYPE
Irradiate
Irradiated
Irradiation
Radiation
Radiation Therapy, NOS
Radiotherapeutics
Radiotherapy
RT
Therapy, Radiation
Energy Type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS) Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.	A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.	From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pathologic Complete Response at Surgery Time Frame: At the time of surgery, 5-8 weeks after completion of radiation therapy.	Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor.	At the time of surgery, 5-8 weeks after completion of radiation therapy.
Overall Survival Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.	Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.	From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
Frequency of Highest Grade Adverse Event Per Participant Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.	Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.	From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
Quality-adjusted Survival Time Frame: From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.		From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.
Molecular Correlates of Efficacy Time Frame: From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.		From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.
Number of Participants With Any Cardiac Adverse Events Regardless of Attribution Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.	Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.	From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment Time Frame: Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start	The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.	Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology

Investigators

Principal Investigator: Howard P Safran, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Safran HP, Winter K, Ilson DH, Wigle D, DiPetrillo T, Haddock MG, Hong TS, Leichman LP, Rajdev L, Resnick M, Kachnic LA, Seaward S, Mamon H, Diaz Pardo DA, Anderson CM, Shen X, Sharma AK, Katz AW, Salo J, Leonard KL, Moughan J, Crane CH. Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):259-269. doi: 10.1016/S1470-2045(21)00718-X. Epub 2022 Jan 14.

Helpful Links

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2011

Primary Completion (Actual)

December 23, 2019

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

September 4, 2010

First Submitted That Met QC Criteria

September 4, 2010

First Posted (Estimated)

September 8, 2010

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

NCI-2011-02601 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180868 (U.S. NIH Grant/Contract)
U10CA180830 (U.S. NIH Grant/Contract)
U10CA021661 (U.S. NIH Grant/Contract)
CDR0000683717
RTOG-1010 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

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Clinical Trials on Esophageal Adenocarcinoma

Clinical Trials on Laboratory Biomarker Analysis

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CROs in Burkina Faso

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