A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma
What treatments are being studied? Cetuximab
Status: Active, not recruiting
Location: See all (264) locations...
Intervention Type: Radiation, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

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

• DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:

• Oral cavity

• Oropharynx

• Larynx

• Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:

• General history and physical examination by a Radiation Oncologist and/or Medical Oncologist

• Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)

• Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for intermediate risk of recurrence:

• Perineural invasion

• Lymphovascular invasion

• Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) (no extracapsular extension)

• Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)

• Pathologically confirmed T3 or T4a primary tumor

• T2 oral cavity cancer with > 5 mm depth of invasion

• No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery

• PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

• Total bilirubin < 2 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN

• Serum creatinine < 2 times ULN OR creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or previously treated carcinoma in situ of the breast, oral cavity, or cervix

• No simultaneous primary or bilateral tumors

• No severe, active co-morbidity, including any of the following:

• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

• Transmural myocardial infarction within the past 6 months

• Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy

• Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to have required oxygen therapy within the past year

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

• AIDS based on current Centers for Disease Control (CDC) definition

• Grade 3-4 electrolyte abnormalities according to CTCAE, v. 4, including any of the following:

• Serum calcium (ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL*

• Glucose < 40 mg/dL or > 250 mg/dL

• Magnesium < 0.9 mg/dL or > 3 mg/dL*

• Potassium < 3.0 mmol/L or > 6 mmol/L*

• Sodium < 130 mmol/L or > 155 mmol/L* NOTE: *Despite intervention to normalize levels.

• No prior allergic reaction to cetuximab

• PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for this cancer

• Prior chemotherapy or anti-EGF therapy for a different cancer allowed

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields

• No concurrent amifostine as a radioprotector

• No concurrent granulocyte colony-stimulating factor or erythropoietin

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Arizona Oncology Associates-West Orange Grove
Tucson
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Mercy San Juan Medical Center
Carmichael
City of Hope
Duarte
UC San Diego Moores Cancer Center
La Jolla
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Los Angeles County-USC Medical Center
Los Angeles
University of Southern California/Norris Cancer Center
Los Angeles
Memorial Medical Center
Modesto
Bay Area Tumor Institute CCOP
Oakland
Pomona Valley Hospital Medical Center
Pomona
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
Mercy General Hospital Radiation Oncology Center
Sacramento
Sutter General Hospital
Sacramento
University of California at Davis Cancer Center
Sacramento
Saint Helena Hospital
Saint Helena
UCSF-Mount Zion
San Francisco
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Stanford University Hospitals and Clinics
Stanford
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora
Penrose-Saint Francis Healthcare
Colorado Springs
Porter Adventist Hospital
Denver
Swedish Medical Center
Englewood
Rocky Mountain Cancer Centers-Littleton
Littleton
Connecticut
Saint Vincent's Medical Center
Bridgeport
Yale University
New Haven
William Backus Hospital
Norwich
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Mayo Clinic in Florida
Jacksonville
Baptist Hospital of Miami
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Florida Hospital
Orlando
UF Cancer Center at Orlando Health
Orlando
Georgia
Emory University/Winship Cancer Institute
Atlanta
Atlanta VA Medical Center
Decatur
Northeast Georgia Medical Center
Gainesville
Memorial Health University Medical Center
Savannah
Saint Joseph's-Candler Health System
Savannah
Hawaii
Queen's Medical Center
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii
Honolulu
Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
University of Iowa Hospitals and Clinics
Iowa City
Siouxland Hematology Oncology Associates
Sioux City
Idaho
Saint Alphonsus Regional Medical Center
Boise
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
University of Illinois
Chicago
NorthShore University HealthSystem-Evanston Hospital
Evanston
Ingalls Memorial Hospital
Harvey
Hines Veterans Administration Hospital
Hines
Loyola University Medical Center
Maywood
Memorial Medical Center
Springfield
Saint John's Hospital
Springfield
Carle Cancer Center
Urbana
Indiana
Parkview Hospital Randallia
Fort Wayne
Radiation Oncology Associates PC
Fort Wayne
Community Regional Cancer Care-East Radiation Oncology
Indianapolis
Community Regional Cancer Care-North
Indianapolis
IU Health Methodist Hospital
Indianapolis
IU Health Ball Memorial Hospital
Muncie
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky
Lexington
The James Graham Brown Cancer Center at University of Louisville
Louisville
Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge
Touro Infirmary
New Orleans
Tulane University Health Sciences Center
New Orleans
Massachusetts
Boston Medical Center
Boston
Tufts Medical Center
Boston
Lahey Hospital and Medical Center
Burlington
Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore
Peninsula Regional Medical Center
Salisbury
Maine
Central Maine Medical Center
Lewiston
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan
Ann Arbor
Oakwood Hospital
Dearborn
Henry Ford Hospital
Detroit
Saint John Hospital and Medical Center
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
West Michigan Cancer Center
Kalamazoo
Saint Mary's of Michigan
Saginaw
Saint John Macomb-Oakland Hospital
Warren
Minnesota
Mercy Hospital
Coon Rapids
Saint Luke's Hospital of Duluth
Duluth
Unity Hospital
Fridley
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Mayo Clinic
Rochester
Regions Hospital
Saint Paul
Missouri
Cape Radiation Oncology
Cape Girardeau
University of Missouri - Ellis Fischel
Columbia
Kansas City Cancer Centers - North
Kansas City
Kansas City Cancer Center-Lee's Summit
Lee's Summit
Barnes-Jewish West County Hospital
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint John's Mercy Medical Center
Saint Louis
Saint Louis University Hospital
Saint Louis
Siteman Cancer Center-South County
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center - Saint Peters
Saint Peters
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
Singing River Hospital
Pascagoula
North Carolina
Mission Hospital-Memorial Campus
Asheville
University of North Carolina
Chapel Hill
Wayne Radiation Oncology
Goldsboro
Kinston Medical Specialists PA
Kinston
Cancer Centers of North Carolina
Raleigh
Wake Forest University Health Sciences
Winston-salem
North Dakota
Roger Maris Cancer Center
Fargo
Nebraska
Saint Elizabeth Regional Medical Center
Lincoln
Nebraska Methodist Hospital
Omaha
The Nebraska Medical Center
Omaha
New Hampshire
Exeter Hospital
Exeter
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly
Saint Peter's University Hospital
New Brunswick
UMDNJ - New Jersey Medical School
Newark
Sparta Cancer Treatment Center
Sparta
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
New Mexico
University of New Mexico
Albuquerque
Nevada
Renown Regional Medical Center
Reno
New York
New York Oncology Hematology PC - Albany
Albany
Maimonides Medical Center
Brooklyn
Sands Cancer Center
Canandaigua
Memorial Sloan Kettering Cancer Center Commack
Commack
Beth Israel Medical Center
New York
Memorial Sloan-Kettering Cancer Center
New York
Highland Hospital
Rochester
University of Rochester
Rochester
University Radiation Oncology
Rochester
Memorial Sloan-Kettering Cancer Center Rockville Centre
Rockville Centre
Memorial Sloan-Kettering Cancer Center at Sleepy Hallow
Sleepy Hollow
Ohio
Akron General Medical Center
Akron
Summa Akron City Hospital/Cooper Cancer Center
Akron
Summa Barberton Hospital
Barberton
Mercy Medical Center
Canton
Geaugra Hospital
Chardon
University of Cincinnati
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Ohio State University Medical Center
Columbus
Mercy Cancer Center-Elyria
Elyria
Cleveland Clinic Cancer Center Independence
Independence
Hillcrest Hospital Cancer Center
Mayfield Heights
Summa Health Center at Lake Medina
Medina
Lake University Ireland Cancer Center
Mentor
Southwest General Health Center Ireland Cancer Center
Middleburg Heights
UHHS-Chagrin Highlands Medical Center
Orange Village
Saint Charles Hospital
Oregon
Robinson Radiation Oncology
Ravenna
North Coast Cancer Care
Sandusky
Cleveland Clinic Cancer Center-Strongsville
Strongsville
Flower Hospital
Sylvania
University Pointe
West Chester
UHHS-Westlake Medical Center
Westlake
Cleveland Clinic Wooster Specialty Center
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Clackamas
Willamette Valley Cancer Center
Eugene
Oregon Health and Science University
Portland
Portland Veterans Administration Medical Center
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Western Oncology Research Consortium
Portland
Salem Hospital
Salem
Pennsylvania
Lehigh Valley Hospital
Allentown
Geisinger Medical Center
Danville
Northeast Radiation Oncology Center
Dunmore
Pocono Medical Center
East Stroudsburg
Adams Cancer Center
Gettysburg
Cherry Tree Cancer Center
Hanover
Saint Mary Medical and Regional Cancer Center
Langhorne
Albert Einstein Medical Center
Philadelphia
Fox Chase Cancer Center
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
Reading Hospital
West Reading
WellSpan Health-York Hospital
York
South Carolina
AnMed Health Cancer Center
Anderson
Medical University of South Carolina
Charleston
Greenville Health System Cancer Institute-Faris
Greenville
Greenville Health System Cancer Institute/Greenville CCOP
Greenville
Gibbs Cancer Center-Pelham
Greer
Greenville Health System Cancer Institute-Spartanburg
Spartanburg
Spartanburg Regional Medical Center
Spartanburg
South Dakota
Rapid City Regional Hospital
Rapid City
Sanford Cancer Center-Oncology Clinic
Sioux Falls
Tennessee
Wellmont Holston Valley Hospital and Medical Center
Kingsport
Vanderbilt-Ingram Cancer Center
Nashville
Texas
Texas Oncology - Central Austin Cancer Center
Austin
Texas Oncology - South Austin Cancer Center
Austin
Texas Oncology-Austin Midtown
Austin
Texas Oncology PA - Bedford
Bedford
University of Texas Southwestern Medical Center
Dallas
Texas Oncology-Denton South
Denton
The Klabzuba Cancer Center
Fort Worth
Ben Taub General Hospital
Houston
M D Anderson Cancer Center
Houston
Memorial Hermann Memorial City Medical Center
Houston
Texas Oncology - Round Rock Cancer Center
Round Rock
Texas Oncology-Seton Williamson
Round Rock
Cancer Care Centers of South Texas- Northeast
San Antonio
University of Texas Health Science Center at San Antonio
San Antonio
Texas Cancer Center-Sherman
Sherman
Texas Oncology Cancer Center Sugar Land
Sugar Land
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls
Utah
Intermountain Medical Center
Murray
Dixie Medical Center Regional Cancer Center
Saint George
Huntsman Cancer Institute/University of Utah
Salt Lake City
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
University of Virginia
Charlottesville
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton
Sentara Hospitals
Norfolk
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond
Virginia Commonwealth University
Richmond
Sentara Virginia Beach General Hospital
Virginia Beach
Washington
Harrison Medical Center
Bremerton
Tri-Cities Cancer Center
Kennewick
Skagit Valley Hospital
Mount Vernon
University of Washington Medical Center
Seattle
Cancer Care Northwest - Spokane South
Spokane
Cancer Care Northwest-North Spokane
Spokane
Northwest CCOP
Tacoma
Compass Oncology Vancouver
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Wenatchee Valley Medical Center
Wenatchee
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Fox Valley Hematology and Oncology
Appleton
Saint Vincent Hospital
Green Bay
Gundersen Lutheran
La Crosse
University of Wisconsin Hospital and Clinics
Madison
Bay Area Medical Center
Marinette
Clement J. Zablocki VA Medical Center
Milwaukee
Froedtert and the Medical College of Wisconsin
Milwaukee
Door County Cancer Center
Sturgeon Bay
Aspirus Regional Cancer Center
Wausau
West Virginia
West Virginia University Healthcare
Morgantown
Wheeling Hospital
Wheeling
Other Locations
Canada
Cross Cancer Institute
Edmonton
London Regional Cancer Program
London
CHUM - Hopital Notre-Dame
Montreal
McGill University Department of Oncology
Montreal
Ottawa Health Research Institute-General Division
Ottawa
CHUQ - Pavilion Hotel-Dieu de Quebec
Quebec City
Allan Blair Cancer Centre
Regina
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke
Doctor H. Bliss Murphy Cancer Centre
St. John's
Health Sciences North
Sudbury
University Health Network-Princess Margaret Hospital
Toronto
CancerCare Manitoba
Winnipeg
China
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh
Time Frame
Start Date: November 2009
Estimated Completion Date: August 2029
Participants
Target number of participants: 703
Treatments
Active Comparator: Arm I: Intensity-Modulated Radiotherapy
Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II: IMRT plus cetuximab
Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.
Authors
Mark C. Smith, Dennis E. Slater, Paul A. DeMare, Gopal R. Desai, William R. Robinson, Eliot L. Friedman, John A. Pablo, Neil D. Gross, Thomas J. Gergel, Gregory J. Kubicek, Roy H. Decker, Sharon A. Spencer, Michael A. Samuels, Robert J. Behrens, Allen M. Chen, Minh T. Truong, Nancy Y. Lee, Scott S. Williams, Miroslaw A. Mazurczak, Jonathan J. Beitler, Albert Yuen, Matthew S. Gordon, Ying Li, Matthew C. Solhjem, Min Yao, Eugene I. Chung, Preston D. Steen, Bhishamjit S. Chera, Patricia C. Griffin, Rex B. Mowat, Raymond S. Lord, Kevin Yiee, Paul W. Sperduto, Vilija N. Avizonis, Yuhchyau Chen, Asheesh Shipstone, Robert W. Veith, Michael C. Hardacre, Wade L. Thorstad, Rafael R. Manon, Alan P. Lyss, Kenneth S. Hu, Joseph J. Merchant, David J. Adelstein, Sue S. Yom, Lawrence E. Feldman, Anand K. Sharma, Matthew L. Snyder, Kevin P. Redmond, Robert J. Sollaccio, Robert L. Foote, Aaron W. Pederson, Alexander M. Yeh, Cheryl M. Czerlanis, Anthony J. Cmelak, Christopher U. Jones, Bruce J. Walz, Harry D. Bear, Erich M. Sturgis, Lucien A. Nedzi, Keren Sturtz, Parvesh Kumar, Paul W. Read, Brian K. Chang, Fred R. Rosen, Manish Monga, David J. Tate, Avraham Eisbruch, Eleanor M. Walker, Weining K. Zhen, Gregory M. Cooley, Mahesh R. Kudrimoti, Thomas J. Galloway, Mitchel L. Fromm, James E. Clarkson, Adam Raben, Steven R. Bonin, Frank G. Lake, Samir Narayan, Donald B. Wender, David L. Grisell, Maura L. Gillison, Michael J. Swartz, Benny J. Liem, Elizabeth M. Gore, Jay S. Cooper, Charles A. Kunos, Peter R. Watson, Collin D. Driscoll, Lemuel S. Ariaratnam, Yunjie X. Lin, Rita S. Axelrod, Ying J. Hitchcock, Edward J. Walsh, Alan C. Hartford, Kathryn M. Greven, Michael R. Girvigian, Donald C. Doll, Jondavid Pollock, James L. Wade, Terence S. Herman, Paul M. Harari, Sulochana D. Yalavarthi, David Raben, Harold E. Kim, Shih J. Wei, Darryl R. Barton, Mark D. Bonnen, Cathy L. Clausen, Vivek S. Kavadi, George E. Laramore, Andre A. Abitbol, Robert R. Kohl, Shiao Y. Woo, Christopher J. Schultz, Rufus A. Scrimger, Samy El-Sayed, Francis W. Nugent, Christopher M. Iannuzzi, Shankar P. Giri, Evgeny Sadikov, Amit B. Shah, George Shenouda, Adam K. Andronowski, Jorge A. Garcia-Young, Nasser M. Al Rajhi, Tien-Shew W. Huang, Michael K. Kam, Christopher H. Chay, Edith J. Filion, Chang S. Wang, John (Joon-Hyung) Kim
Sponsors
Leads: Radiation Therapy Oncology Group
Collaborators: NRG Oncology, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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