Randomized Phase II/III Trial of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma that have undergone gross total surgical resection
Status: Recruiting
Location: See all (289) locations...
Intervention Type: Other, Drug, Radiation, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• PHASE II INCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)

• Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx

• Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible

• Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)

• Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:

• General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;

• Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation

• Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave

• Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement

• Zubrod performance status of 0-1 within 14 days prior to registration

• Absolute granulocyte count (AGC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)

• Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)

• Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

• Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration

• Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula

• Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential

• The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator's discretion

• Patients with feeding tubes are eligible for the study

• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control

• Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis

• PHASE III: Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx

• PHASE III: Patients with oropharyngeal cancer must have p16-negative based on central review prior to Step 2 registration; all patients with oropharyngeal primary must consent for mandatory tissue submission for central p16 confirmation

• PHASE III: Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible

• PHASE III: Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink or tumor in a final separately submitted margin)

• PHASE III: Pathologic stage III or IV HNSCC (American Joint Committee on Cancer [AJCC] 7th edition), including no distant metastases, based upon the following minimum diagnostic workup:

• General history and physical examination by a radiation oncologist or medical oncologist within 84 days prior to registration;

• Examination by an ENT or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror or fiberoptic or direct procedure), if appropriate, is recommended but not required. Intra-operative examination is acceptable documentation.

• Pre-op Imaging of the head and neck: A neck CT (with contrast and of diagnostic quality) or PET/CT (with contrast and of diagnostic quality) and/or an MRI of the neck of diagnostic quality (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in DICOM format via TRIAD. The report is to be uploaded into Rave.

• Chest CT scan (with or without contrast) or PET/CT that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: If the PET/CT with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement

• PHASE III: Zubrod performance status of 0-1 within 14 days prior to registration

• PHASE III: Leukocytes >= 2,500 cells/mm^3 (obtained within 14 days prior to registration on study)

• PHASE III: Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)

• PHASE III: Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)

• PHASE III: Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable) (obtained within 14 days prior to registration on study)

• PHASE III: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x institutional ULN may be enrolled) (within 14 days prior to registration)

• PHASE III: AST or ALT =< 3 x institutional ULN (within 14 days prior to registration)

• PHASE III: Alkaline phosphatase =< 2.5 x institutional ULN (within 14 days prior to registration)

• PHASE III: Creatinine clearance (CrCl) >= 50 mL/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula

• PHASE III: Patients with feeding tubes are eligible for the study

• PHASE III: Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential

• PHASE III: All patients must provide study specific informed consent prior to study entry

• PHASE III: Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:

• A stable regimen of highly active anti-retroviral therapy (HAART);

• No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections;

• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests

Locations
United States
Alabama
The Kirklin Clinic at Acton Road
Suspended
Birmingham
University of Alabama at Birmingham Cancer Center
Recruiting
Birmingham
Arkansas
University of Arkansas for Medical Sciences
Active, not recruiting
Little Rock
Arizona
Banner University Medical Center - Tucson
Recruiting
Tucson
University of Arizona Cancer Center-North Campus
Recruiting
Tucson
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Recruiting
Auburn
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Recruiting
Burbank
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Recruiting
Cameron Park
Mercy San Juan Medical Center
Suspended
Carmichael
UC San Diego Moores Cancer Center
Recruiting
La Jolla
Cedars Sinai Medical Center
Recruiting
Los Angeles
Memorial Medical Center
Recruiting
Modesto
UC Irvine Health/Chao Family Comprehensive Cancer Center
Recruiting
Orange
Stanford Cancer Institute Palo Alto
Recruiting
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
Recruiting
Roseville
Sutter Medical Center Sacramento
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Saint Helena Hospital
Active, not recruiting
Saint Helena
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
UCSF Medical Center-Mount Zion
Recruiting
San Francisco
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Recruiting
Vacaville
Colorado
University of Colorado Hospital
Active, not recruiting
Aurora
Rocky Mountain Cancer Centers-Boulder
Recruiting
Boulder
Penrose-Saint Francis Healthcare
Recruiting
Colorado Springs
Porter Adventist Hospital
Recruiting
Denver
Shaw Cancer Center
Recruiting
Edwards
North Colorado Medical Center
Suspended
Greeley
Rocky Mountain Cancer Centers-Littleton
Recruiting
Littleton
Longmont United Hospital
Recruiting
Longmont
McKee Medical Center
Suspended
Loveland
Parker Adventist Hospital
Recruiting
Parker
Connecticut
University of Connecticut
Active, not recruiting
Farmington
Yale University
Recruiting
New Haven
Smilow Cancer Hospital Care Center - Waterford
Recruiting
Waterford
Washington, D.c.
George Washington University Medical Center
Recruiting
Washington
Delaware
Christiana Care Health System-Christiana Hospital
Suspended
Newark
Helen F Graham Cancer Center
Suspended
Newark
Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Active, not recruiting
Deerfield Beach
University of Miami Miller School of Medicine-Sylvester Cancer Center
Active, not recruiting
Miami
AdventHealth Orlando
Active, not recruiting
Orlando
Orlando Health Cancer Institute
Recruiting
Orlando
Moffitt Cancer Center
Suspended
Tampa
Georgia
Emory University Hospital Midtown
Recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Recruiting
Atlanta
Augusta University Medical Center
Recruiting
Augusta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Suspended
Savannah
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Queen's Medical Center
Active, not recruiting
Honolulu
The Cancer Center of Hawaii-Liliha
Active, not recruiting
Honolulu
Iowa
McFarland Clinic PC - Ames
Active, not recruiting
Ames
Iowa Methodist Medical Center
Suspended
Des Moines
Idaho
Saint Alphonsus Medical Center-Nampa
Recruiting
Nampa
Illinois
John H Stroger Jr Hospital of Cook County
Recruiting
Chicago
Northwestern University
Recruiting
Chicago
Rush University Medical Center
Recruiting
Chicago
University of Illinois
Active, not recruiting
Chicago
Decatur Memorial Hospital
Recruiting
Decatur
Crossroads Cancer Center
Recruiting
Effingham
NorthShore University HealthSystem-Evanston Hospital
Recruiting
Evanston
NorthShore University HealthSystem-Glenbrook Hospital
Recruiting
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Recruiting
Highland Park
Advocate Christ Medical Center
Recruiting
Oak Lawn
OSF Saint Francis Medical Center
Recruiting
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Recruiting
Peoria
SwedishAmerican Regional Cancer Center/ACT
Recruiting
Rockford
Memorial Medical Center
Recruiting
Springfield
Carle Cancer Center
Recruiting
Urbana
Indiana
Ascension Saint Vincent Anderson
Active, not recruiting
Anderson
Elkhart General Hospital
Active, not recruiting
Elkhart
Parkview Hospital Randallia
Active, not recruiting
Fort Wayne
Parkview Regional Medical Center
Active, not recruiting
Fort Wayne
Radiation Oncology Associates PC
Suspended
Fort Wayne
Goshen Center for Cancer Care
Active, not recruiting
Goshen
Indiana University/Melvin and Bren Simon Cancer Center
Suspended
Indianapolis
IU Health Central Indiana Cancer Centers-East
Active, not recruiting
Indianapolis
IU Health Methodist Hospital
Suspended
Indianapolis
Michiana Hematology Oncology PC-Mishawaka
Active, not recruiting
Mishawaka
Memorial Hospital of South Bend
Active, not recruiting
South Bend
Kansas
University of Kansas Cancer Center
Recruiting
Kansas City
Olathe Health Cancer Center
Recruiting
Olathe
University of Kansas Cancer Center-Overland Park
Recruiting
Overland Park
Salina Regional Health Center
Recruiting
Salina
Kentucky
University of Kentucky/Markey Cancer Center
Active, not recruiting
Lexington
The James Graham Brown Cancer Center at University of Louisville
Recruiting
Louisville
Louisiana
Ochsner Medical Center Jefferson
Active, not recruiting
New Orleans
Tulane University Health Sciences Center
Active, not recruiting
New Orleans
Massachusetts
Boston Medical Center
Recruiting
Boston
Maryland
Greater Baltimore Medical Center
Recruiting
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
UM Upper Chesapeake Medical Center
Recruiting
Bel Air
Central Maryland Radiation Oncology in Howard County
Recruiting
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
Recruiting
Glen Burnie
Holy Cross Hospital
Active, not recruiting
Silver Spring
Michigan
Saint Joseph Mercy Hospital
Recruiting
Ann Arbor
University of Michigan Comprehensive Cancer Center
Active, not recruiting
Ann Arbor
Saint Joseph Mercy Brighton
Recruiting
Brighton
University of Michigan - Brighton Center for Specialty Care
Active, not recruiting
Brighton
Henry Ford Cancer Institute-Downriver
Recruiting
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township
Henry Ford Hospital
Recruiting
Detroit
Spectrum Health at Butterworth Campus
Recruiting
Grand Rapids
West Michigan Cancer Center
Recruiting
Kalamazoo
Trinity Health Saint Mary Mercy Livonia Hospital
Recruiting
Livonia
William Beaumont Hospital-Royal Oak
Active, not recruiting
Royal Oak
Ascension Saint Mary's Hospital
Recruiting
Saginaw
William Beaumont Hospital - Troy
Active, not recruiting
Troy
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield
Minnesota
Sanford Joe Lueken Cancer Center
Recruiting
Bemidji
Miller-Dwan Hospital
Recruiting
Duluth
Hennepin County Medical Center
Recruiting
Minneapolis
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Saint Francis Medical Center
Recruiting
Cape Girardeau
University of Missouri - Ellis Fischel
Active, not recruiting
Columbia
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
North Kansas City Hospital
Suspended
Kansas City
The University of Kansas Cancer Center-South
Suspended
Kansas City
University of Kansas Cancer Center - North
Recruiting
Kansas City
University of Kansas Cancer Center - Lee's Summit
Recruiting
Lee's Summit
Delbert Day Cancer Institute at PCRMC
Recruiting
Rolla
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Missouri Baptist Medical Center
Recruiting
Saint Louis
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
CoxHealth South Hospital
Recruiting
Springfield
Mercy Hospital Springfield
Recruiting
Springfield
Mississippi
University of Mississippi Medical Center
Suspended
Jackson
North Carolina
Atrium Health Stanly/LCI-Albemarle
Recruiting
Albemarle
UNC Lineberger Comprehensive Cancer Center
Active, not recruiting
Chapel Hill
Atrium Health Pineville/LCI-Pineville
Recruiting
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Atrium Health Cabarrus/LCI-Concord
Recruiting
Concord
East Carolina University
Recruiting
Greenville
Vidant Oncology-Kinston
Recruiting
Kinston
Atrium Health Union/LCI-Union
Recruiting
Monroe
Wake Forest University Health Sciences
Active, not recruiting
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Recruiting
Bismarck
Sanford Roger Maris Cancer Center
Recruiting
Fargo
Nebraska
CHI Health Good Samaritan
Recruiting
Kearney
Alegent Health Bergan Mercy Medical Center
Recruiting
Omaha
Nebraska Methodist Hospital
Active, not recruiting
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
Recruiting
Basking Ridge
Memorial Sloan Kettering Monmouth
Recruiting
Middletown
Memorial Sloan Kettering Bergen
Recruiting
Montvale
Virtua Memorial
Active, not recruiting
Mount Holly
Sparta Cancer Treatment Center
Suspended
Sparta
Virtua Voorhees
Active, not recruiting
Voorhees
New Mexico
New Mexico Oncology Hematology Consultants
Recruiting
Albuquerque
University of New Mexico Cancer Center
Recruiting
Albuquerque
New York
South Shore University Hospital
Active, not recruiting
Bay Shore
New York-Presbyterian/Brooklyn Methodist Hospital
Suspended
Brooklyn
Roswell Park Cancer Institute
Recruiting
Buffalo
Sands Cancer Center
Recruiting
Canandaigua
Memorial Sloan Kettering Commack
Recruiting
Commack
Arnot Ogden Medical Center/Falck Cancer Center
Recruiting
Elmira
Memorial Sloan Kettering Westchester
Recruiting
Harrison
Northwell Health/Center for Advanced Medicine
Active, not recruiting
Lake Success
NYU Winthrop Hospital
Recruiting
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Recruiting
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Mount Sinai Union Square
Suspended
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Active, not recruiting
New York
Highland Hospital
Recruiting
Rochester
University of Rochester
Recruiting
Rochester
Wilmot Cancer Institute Radiation Oncology at Greece
Suspended
Rochester
Memorial Sloan Kettering Sleepy Hollow
Suspended
Sleepy Hollow
State University of New York Upstate Medical University
Recruiting
Syracuse
Memorial Sloan Kettering Nassau
Recruiting
Uniondale
Ohio
Cleveland Clinic Akron General
Active, not recruiting
Akron
Summa Health System - Akron Campus
Active, not recruiting
Akron
Summa Health System - Barberton Campus
Active, not recruiting
Barberton
UHHS-Chagrin Highlands Medical Center
Recruiting
Beachwood
Geauga Hospital
Recruiting
Chardon
Adena Regional Medical Center
Recruiting
Chillicothe
University of Cincinnati Cancer Center-UC Medical Center
Recruiting
Cincinnati
Case Western Reserve University
Recruiting
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Recruiting
Cleveland
Cleveland Clinic Foundation
Recruiting
Cleveland
MetroHealth Medical Center
Recruiting
Cleveland
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Mercy Cancer Center-Elyria
Suspended
Elyria
Cleveland Clinic Cancer Center Independence
Suspended
Independence
OhioHealth Mansfield Hospital
Recruiting
Mansfield
Hillcrest Hospital Cancer Center
Recruiting
Mayfield Heights
Summa Health Medina Medical Center
Active, not recruiting
Medina
UH Seidman Cancer Center at Lake Health Mentor Campus
Recruiting
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Recruiting
Middleburg Heights
University Hospitals Parma Medical Center
Recruiting
Parma
Southern Ohio Medical Center
Recruiting
Portsmouth
University Hospitals Portage Medical Center
Recruiting
Ravenna
North Coast Cancer Care
Recruiting
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Recruiting
Sandusky
Cleveland Clinic Cancer Center Strongsville
Recruiting
Strongsville
University of Cincinnati Cancer Center-West Chester
Recruiting
West Chester
UHHS-Westlake Medical Center
Recruiting
Westlake
Cleveland Clinic Wooster Family Health and Surgery Center
Recruiting
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Recruiting
Clackamas
Providence Portland Medical Center
Recruiting
Portland
Providence Saint Vincent Medical Center
Recruiting
Portland
Pennsylvania
UPMC Altoona
Recruiting
Altoona
UPMC-Heritage Valley Health System Beaver
Recruiting
Beaver
Carlisle Regional Cancer Center
Recruiting
Carlisle
UPMC Hillman Cancer Center Erie
Recruiting
Erie
UPMC Cancer Center at UPMC Horizon
Recruiting
Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion
Recruiting
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Recruiting
Harrisburg
Penn State Milton S Hershey Medical Center
Recruiting
Hershey
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Recruiting
Johnstown
UPMC Cancer Center at UPMC McKeesport
Recruiting
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Recruiting
Mechanicsburg
UPMC Cancer Center - Monroeville
Recruiting
Monroeville
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Recruiting
Moon
UPMC Cancer Center-Natrona Heights
Suspended
Natrona Heights
UPMC Jameson
Suspended
New Castle
Fox Chase Cancer Center
Recruiting
Philadelphia
Temple University Hospital
Recruiting
Philadelphia
Thomas Jefferson University Hospital
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
UPMC Jefferson Regional Radiation Oncology
Suspended
Pittsburgh
UPMC-Magee Womens Hospital
Recruiting
Pittsburgh
UPMC-Passavant Hospital
Recruiting
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Recruiting
Pittsburgh
UPMC-Saint Margaret
Recruiting
Pittsburgh
UPMC-Shadyside Hospital
Recruiting
Pittsburgh
UPMC Cancer Center at UPMC Northwest
Recruiting
Seneca
UPMC Uniontown Hospital Radiation Oncology
Recruiting
Uniontown
UPMC Washington Hospital Radiation Oncology
Recruiting
Washington
Reading Hospital
Suspended
West Reading
Wexford Health and Wellness Pavilion
Recruiting
Wexford
South Carolina
AnMed Health Cancer Center
Suspended
Anderson
Saint Joseph's/Candler - Bluffton Campus
Suspended
Bluffton
Prisma Health Cancer Institute - Spartanburg
Suspended
Boiling Springs
Prisma Health Cancer Institute - Eastside
Recruiting
Greenville
Prisma Health Cancer Institute - Faris
Recruiting
Greenville
Gibbs Cancer Center-Pelham
Recruiting
Greer
Prisma Health Cancer Institute - Greer
Recruiting
Greer
Prisma Health Cancer Institute - Seneca
Recruiting
Seneca
Spartanburg Medical Center
Recruiting
Spartanburg
South Dakota
Rapid City Regional Hospital
Active, not recruiting
Rapid City
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
Vanderbilt University/Ingram Cancer Center
Active, not recruiting
Nashville
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
University of Texas Medical Branch
Recruiting
Galveston
M D Anderson Cancer Center
Recruiting
Houston
UTMB Cancer Center at Victory Lakes
Recruiting
League City
Covenant Medical Center-Lakeside
Active, not recruiting
Lubbock
Utah
Intermountain Medical Center
Active, not recruiting
Murray
Saint George Regional Medical Center
Active, not recruiting
Saint George
Huntsman Cancer Institute/University of Utah
Recruiting
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Active, not recruiting
Salt Lake City
Virginia
Inova Fairfax Hospital
Active, not recruiting
Falls Church
Sentara Cancer Institute at Sentara CarePlex Hospital
Active, not recruiting
Hampton
Sentara Norfolk General Hospital
Active, not recruiting
Norfolk
Virginia Commonwealth University/Massey Cancer Center
Active, not recruiting
Richmond
Sentara Virginia Beach General Hospital
Active, not recruiting
Virginia Beach
Washington
Saint Francis Hospital
Recruiting
Federal Way
Tri-Cities Cancer Center
Suspended
Kennewick
PeaceHealth Saint John Medical Center
Recruiting
Longview
Skagit Regional Health Cancer Care Center
Recruiting
Mount Vernon
University of Washington Medical Center - Montlake
Recruiting
Seattle
Spokane Valley Cancer Center-Mayfair
Suspended
Spokane
Spokane Valley Cancer Center-Mission
Suspended
Spokane
Wenatchee Valley Hospital and Clinics
Recruiting
Wenatchee
Wisconsin
Langlade Hospital and Cancer Center
Recruiting
Antigo
Saint Vincent Hospital Cancer Center at Saint Mary's
Recruiting
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Recruiting
Green Bay
UW Cancer Center Johnson Creek
Recruiting
Johnson Creek
Gundersen Lutheran Medical Center
Recruiting
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Suspended
La Crosse
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Bay Area Medical Center
Active, not recruiting
Marinette
Marshfield Medical Center
Active, not recruiting
Marshfield
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls
Medical College of Wisconsin
Recruiting
Milwaukee
Marshfield Clinic-Minocqua Center
Active, not recruiting
Minocqua
Drexel Town Square Health Center
Recruiting
Oak Creek
Ascension Saint Michael's Hospital
Active, not recruiting
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Recruiting
Sturgeon Bay
Aspirus Regional Cancer Center
Recruiting
Wausau
Froedtert West Bend Hospital/Kraemer Cancer Center
Recruiting
West Bend
Aspirus Cancer Care - Wisconsin Rapids
Recruiting
Wisconsin Rapids
West Virginia
West Virginia University Healthcare
Recruiting
Morgantown
Wheeling Hospital/Schiffler Cancer Center
Suspended
Wheeling
Other Locations
Canada
Cross Cancer Institute
Recruiting
Edmonton
Allan Blair Cancer Centre
Recruiting
Regina
Saskatoon Cancer Centre
Recruiting
Saskatoon
China
Chinese University of Hong Kong-Prince of Wales Hospital
Active, not recruiting
Shatin
Time Frame
Start Date: March 18, 2013
Estimated Completion Date: January 1, 2027
Participants
Target number of participants: 613
Treatments
Experimental: Arm 1 (IMRT, cisplatin)
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks.
Experimental: Arm 2 (IMRT, docetaxel)
Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. (CLOSED AS OF 20-MAR-2020)
Experimental: Arm 3 (IMRT, docetaxel, cetuximab)
Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks.
Experimental: Arm 4 (IMRT, cisplatin, atezolizumab)
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity.
Authors
Michael E. Kupferman, Laila A. Gharzai, Sinisa Stanic, Mitchell Machtay, Neil D. Gross, Sharon A. Spencer, Kiran K. Yalamanchili, Chi K. Tsang, Minh T. Truong, Matthew L. Ryan, Charles Shideman, Nancy Y. Lee, Scott S. Williams, Jonathan J. Beitler, Jennifer A. Dorth, Larisa Greenberg, Bryan A. Faller, Mohammed Almubarak, Min Yao, Preston D. Steen, Benjamin J. Moeller, Kendra M. Harris, Julie E. Bauman, Paul W. Sperduto, Jason Chan, Yuhchyau Chen, Rupali Nabar, Jay W. Carlson, Wade L. Thorstad, Rafael R. Manon, Kenneth S. Hu, James E. Bates, Neal E. Dunlap, Matthew J. Ferris, David J. Adelstein, David J. Sher, Loren K. Mell, Sue S. Yom, Kevin P. Redmond, Robert L. Foote, Lee R. Wiederhold, Anurag K. Singh, Aaron W. Pederson, Ana P. Kiess, Ricklie A. Julian, Jessica L. Geiger, Thomas E. Lad, Timothy D. Moore, Bruce E. Brockstein, Zachary S. Zumsteg, Christopher U. Jones, Emory McTyre, Krishna C. Alluri, John M. Schallenkamp, Michael L. Haas, Sara Medek, Jennifer M. Johnson, Brian K. Chang, Thomas M. Schroeder, Matthew E. Witek, Patricia H. Hardenbergh, Shyam S. Rao, Eleanor M. Walker, R. J. Lee, Thomas J. Galloway, Michael D. Zurenko, Joshua T. Mckenzie, Adam Raben, Misbah U. Qadir, Samir Narayan, Nicholas DiBella, Christina Henson, Seung S. Hahn, Nikhil P. Joshi, Collin D. Driscoll, Bharat B. Mittal, Heath D. Skinner, Francis P. Worden, Ying J. Hitchcock, Dan S. Zuckerman, Sana D. Karam, Andrew W. Ju, Cristina P. Rodriguez, Jondavid Pollock, Siddharth Sheth, Michael Gensheimer, Paul Harari, Quynh-Thu X. Le, Harvey E. Einhorn, Bret E. Friday, Melissa R. Young, Richard L. Deming, Nakhle S. Saba, Deric C. Savior, Christopher J. Schultz, Christopher S. Platta, Joshua Giambattista, Krishnamurthi Sundaram, Ali A. El-Gayed, Evgeny Sadikov, Brock J. Debenham, Rami Y. Haddad, Christopher Lominska, Katharine A. Price, Sharad A. Ghamande, Jimmy J. Caudell, Dukagjin M. Blakaj, Amarinthia (Amy) Curtis, Tien-Shew W. Huang, David A. Clump, Kathleen J. Yost, Nitya Alluri, Mei Tang, William Tse, William Stokes
Sponsors
Collaborators: NRG Oncology
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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