Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Esophageal Cancer AJCC v7
About this trial
This is an interventional treatment trial for Esophageal Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- The Kirklin Clinic at Acton Road
- Providence Hospital
- Alaska Breast Care and Surgery LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Mayo Clinic Hospital in Arizona
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- Kaiser Permanente-Deer Valley Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- East Bay Radiation Oncology Center
- Enloe Medical Center
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Marin General Hospital
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- El Camino Hospital
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Valley Medical Oncology Consultants
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Midstate Medical Center
- Middlesex Hospital
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- William Backus Hospital
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Christiana Care Health System-Wilmington Hospital
- AdventHealth Altamonte
- AdventHealth Kissimmee
- Miami Cancer Institute
- AdventHealth Orlando
- AdventHealth East Orlando
- Robert and Carol Weissman Cancer Center at Martin Health
- AdventHealth Winter Park
- Grady Health System
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Piedmont Fayette Hospital
- Northeast Georgia Medical Center-Gainesville
- Medical Center of Central Georgia
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Health - Coeur d'Alene
- Saint Joseph Regional Medical Center
- Kootenai Clinic Cancer Services - Post Falls
- Northwest Community Hospital
- Mac Neal Hospital
- Memorial Hospital of Carbondale
- Centralia Oncology Clinic
- Northwestern University
- University of Illinois
- Weiss Memorial Hospital
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Ingalls Memorial Hospital
- Presence Saint Mary's Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Good Samaritan Regional Health Center
- Advocate Christ Medical Center
- West Suburban Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Memorial Medical Center
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Franciscan Health Indianapolis
- Community Howard Regional Health
- IU Health La Porte Hospital
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- IU Health Ball Memorial Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- McFarland Clinic - Boone
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Mercy Medical Center - Des Moines
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Mercy Medical Center-West Lakes
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Kansas City NCI Community Oncology Research Program
- Salina Regional Health Center
- Oncology Hematology Care Inc-Crestview
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Ochsner Medical Center Jefferson
- Central Maine Medical Center
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical Center
- UM Upper Chesapeake Medical Center
- TidalHealth Peninsula Regional
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Berkshire Medical Center - Cancer Center
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- D'Amour Center for Cancer Care
- Baystate Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Green Bay Oncology - Iron Mountain
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Methodist Hospital
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- Renown Regional Medical Center
- Concord Hospital
- Wentworth-Douglass Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Rutgers New Jersey Medical School
- Newark Beth Israel Medical Center
- Capital Health Medical Center-Hopewell
- Sparta Cancer Treatment Center
- Overlook Hospital
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- University of New Mexico Cancer Center
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Sands Cancer Center
- Memorial Sloan Kettering Commack
- Glens Falls Hospital
- Memorial Sloan Kettering Westchester
- Mount Sinai Union Square
- Mount Sinai West
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- Wilmot Cancer Institute Radiation Oncology at Greece
- Highland Hospital
- University of Rochester
- Memorial Sloan Kettering Sleepy Hollow
- Memorial Sloan Kettering Nassau
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Pineville/LCI-Pineville
- Atrium Health Cabarrus/LCI-Concord
- Vidant Oncology-Kinston
- Matthews Radiation Oncology Center
- Atrium Health Union/LCI-Union
- UNC Rex Healthcare
- Wake Forest University Health Sciences
- Essentia Health Cancer Center-South University Clinic
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Summa Health System - Barberton Campus
- UHHS-Chagrin Highlands Medical Center
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Geauga Hospital
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati Cancer Center-UC Medical Center
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve University
- MetroHealth Medical Center
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Summa Health Medina Medical Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- University Hospitals Portage Medical Center
- UH Seidman Cancer Center at Salem Regional Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- UHHS-Westlake Medical Center
- Cancer Treatment Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Salem Hospital
- UPMC-Heritage Valley Health System Beaver
- Bryn Mawr Hospital
- Geisinger Medical Center
- Delaware County Memorial Hospital
- Northeast Radiation Oncology Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center in Coraopolis
- Allegheny Valley Hospital
- UPMC Cancer Center-Natrona Heights
- UPMC Jameson
- Paoli Memorial Hospital
- American College of Radiology Imaging Network
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Allegheny General Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading Hospital
- Wexford Health and Wellness Pavilion
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- Rhode Island Hospital
- Radiation Oncology Associates Incorporated
- Miriam Hospital
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Greenville Health System Cancer Institute-Andrews
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Rock Hill Radiation Therapy Center
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Vanderbilt University/Ingram Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- Houston Methodist Hospital
- UTMB Cancer Center at Victory Lakes
- Covenant Medical Center-Lakeside
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Norris Cotton Cancer Center-North
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Southwest VA Regional Cancer Center
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- Olympic Medical Cancer Care Center
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Wenatchee Valley Hospital and Clinics
- West Virginia University Charleston Division
- Wheeling Hospital/Schiffler Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Zablocki Veterans Administration Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (radiotherapy, chemotherapy, trastuzumab)
Arm II (radiotherapy and chemotherapy)
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.
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.