Head and Neck Cancer Clinical Trial
Official title:
A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas
Verified date | May 2022 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 940 |
Est. completion date | May 20, 2022 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; - Selected stage III or IV disease (T2N2-3M0, T3-4 any N M0); Note: Patients with T1, any N, or T2N1 tumors are not eligible. - Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: - History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months and an examination by a Medical Oncologist; - Chest x-ray (or Chest CT scan or PET/CT scan) within 6 weeks prior to registration; - CT scan or MRI of the head and neck (of the primary tumor and neck nodes) or PET/CT scan within 6 weeks prior to registration; see Section 6.11 for details of PET scans. Note: A PET/CT can only be used instead of a CT scan or MRI if the CT is a high quality scan with contrast. - Left ejection fraction determined by echocardiogram and/or multiple gated acquisition (MUGA) technique within 12 weeks of registration; - Zubrod Performance Status 0-1; - Age > 18; - Adequate bone marrow function, defined as follows: - Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study; - Platelets > 100,000 cells/mm3 based upon complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study; - Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.) - Adequate hepatic function, defined as follows: - Bilirubin < 1.5 mg/dl within 2 weeks prior to registration on study; For patients with Gilbert's disease as the sole cause of elevated bilirubin, please contact the PI, Dr. Ang. - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x the upper limit of normal within 2 weeks prior to registration on study; - Adequate renal function, defined as follows: - Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration - Creatinine clearance (CCr) = 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male) - Pregnancy test within 2 weeks prior to registration for women of childbearing potential; - Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment); - Patient must sign study specific informed consent prior to study entry. Exclusion criteria: - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; - Patients with simultaneous primaries or bilateral tumors are excluded. - Gross total excision (e.g., by tonsillectomy) of the primary tumor; however, partial removal of the tumor to alleviate an impending airway obstruction does not make the patient ineligible. - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; - Primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands; - Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted. - Severe, active co-morbidity, defined as follows: - Current uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction; - Left Ventricular Ejection Fraction < 45%; - Transmural myocardial infarction within the last 6 months; - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; - Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. - Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study procedures; - CTCAE, v. 3.0 grade 3-4 electrolyte abnormalities: - Calcium < 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 mmol/L or > 6 mmol/L; - Sodium < 130 mmol/L or > 155 mmol/L - Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. - Prior allergic reaction to the study drug(s) involved in this protocol; - Prior therapy that specifically and directly targets the EGFR pathway; - Prior severe infusion reaction to a monoclonal antibody. |
Country | Name | City | State |
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Canada | Tom Baker Cancer Centre - Calgary | Calgary | Alberta |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Hopital Notre-Dame du CHUM | Montreal | Quebec |
Canada | McGill Cancer Centre at McGill University | Montreal | Quebec |
Canada | Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario |
Canada | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan |
Canada | Northeastern Ontario Regional Cancer Centre | Sudbury | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio |
United States | New Mexico Cancer Center | Albuquerque | New Mexico |
United States | INOVA Alexandria Hospital | Alexandria | Virginia |
United States | Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana |
United States | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | Providence Cancer Center | Anchorage | Alaska |
United States | Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Theda Care Cancer Institute | Appleton | Wisconsin |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory Crawford Long Hospital | Atlanta | Georgia |
United States | Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta | Georgia |
United States | Northside Hospital Cancer Center | Atlanta | Georgia |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Saint Joseph's Hospital of Atlanta | Atlanta | Georgia |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Auburn Radiation Oncology | Auburn | California |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | St. Agnes Hospital Cancer Center | Baltimore | Maryland |
United States | Good Shepherd Hospital | Barrington | Illinois |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | Pennington Cancer Center at Baton Rouge General | Baton Rouge | Louisiana |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Tufts-NEMC Cancer Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Ocean Medical Center at Meridian Health | Brick | New Jersey |
United States | Maimonides Cancer Center at Maimonides Medical Center | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Peninsula Medical Center | Burlingame | California |
United States | Lahey Clinic Medical Center - Burlington | Burlington | Massachusetts |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Radiation Oncology Centers - Cameron Park | Cameron Park | California |
United States | Cancer Institute of Cape Girardeau, LLC | Cape Girardeau | Missouri |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Cape Girardeau | Missouri |
United States | Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California |
United States | East Bay Radiation Oncology Center | Castro Valley | California |
United States | Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California |
United States | Sandra L. Maxwell Cancer Center | Cedar City | Utah |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago | Illinois |
United States | John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Illinois Cancer Center | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Cancer Care Center at John Muir Health - Concord Campus | Concord | California |
United States | Dartmouth - Hitchcock Concord | Concord | New Hampshire |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Bay Area Hospital | Coos Bay | Oregon |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | Mercy Fitzgerald Hospital | Darby | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan |
United States | Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota |
United States | Northeast Radiation Oncology Center | Dunmore | Pennsylvania |
United States | Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg | Pennsylvania |
United States | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | St. Francis Hospital | Federal Way | Washington |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Poudre Valley Radiation Oncology | Fort Collins | Colorado |
United States | Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Parkview Regional Cancer Center at Parkview Health | Fort Wayne | Indiana |
United States | Radiation Oncology Associates Southwest | Fort Wayne | Indiana |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Valley Medical Oncology | Fremont | California |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Virginia K. Crosson Cancer Center at St. Jude Medical Center | Fullerton | California |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois |
United States | Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | Center for Cancer Care at Goshen General Hospital | Goshen | Indiana |
United States | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Three Rivers Community Hospital | Grants Pass | Oregon |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Marin Cancer Institute at Marin General Hospital | Greenbrae | California |
United States | Sutter Health - Western Division Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida |
United States | M. D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | Independence Regional Health Center | Independence | Missouri |
United States | Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | Baptist Medical Center South | Jacksonville | Florida |
United States | Integrated Community Oncology Network at Southside Cancer Center | Jacksonville | Florida |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Integrated Community Oncology Network | Jacksonville Beach | Florida |
United States | Princeton Radiation Oncology Center | Jamesburg | New Jersey |
United States | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois |
United States | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Parvin Radiation Oncology | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri |
United States | St. Joseph Medical Center | Kansas City | Missouri |
United States | Truman Medical Center - Hospital Hill | Kansas City | Missouri |
United States | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska |
United States | Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Liberty Hospital | Liberty | Missouri |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Lynchburg Hematology-Oncology Clinic | Lynchburg | Virginia |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin |
United States | Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire |
United States | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota |
United States | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Dubs Cancer Center at Rogue Valley Medical Center | Medford | Oregon |
United States | Providence Cancer Center at PMCC | Medford | Oregon |
United States | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin |
United States | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Upper Delaware Valley Cancer Center | Milford | Pennsylvania |
United States | Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Memorial Medical Center | Modesto | California |
United States | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah |
United States | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Medical Center of Louisiana - New Orleans | New Orleans | Louisiana |
United States | St. Vincent's Comprehensive Cancer Center - Manhattan | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Alta Bates Summit Medical Center - Summit Campus | Oakland | California |
United States | Bay Area Breast Surgeons, Incorporated | Oakland | California |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Larry G Strieff MD Medical Corporation | Oakland | California |
United States | Tom K Lee, Incorporated | Oakland | California |
United States | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin |
United States | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields | Illinois |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | Methodist Estabrook Cancer Center | Omaha | Nebraska |
United States | Integrated Community Oncology Network - Orange Park | Orange Park | Florida |
United States | M.D. Anderson Cancer Center at Orlando | Orlando | Florida |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Florida Cancer Center - Palatka | Palatka | Florida |
United States | Bay Medical | Panama City | Florida |
United States | Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi |
United States | NSMC Cancer Center - Peabody | Peabody | Massachusetts |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Adventist Medical Center | Portland | Oregon |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon |
United States | Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon |
United States | Oregon Health and Science University Cancer Institute | Portland | Oregon |
United States | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | University Medical Center at Princeton | Princeton | New Jersey |
United States | Miriam Hospital | Providence | Rhode Island |
United States | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Cancer Centers of North Carolina - Raleigh | Raleigh | North Carolina |
United States | Rex Cancer Center at Rex Hospital | Raleigh | North Carolina |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | St. Joseph Medical Center | Reading | Pennsylvania |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Veterans Affairs Medical Center - Richmond | Richmond | Virginia |
United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | Southern Regional Medical Center | Riverdale | Georgia |
United States | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Highland Hospital of Rochester | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford | Illinois |
United States | Swedish-American Regional Cancer Center | Rockford | Illinois |
United States | Radiation Oncology Center - Roseville | Roseville | California |
United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
United States | Mercy General Hospital | Sacramento | California |
United States | Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Flagler Cancer Center | Saint Augustine | Florida |
United States | Dixie Regional Medical Center - East Campus | Saint George | Utah |
United States | Norris Cotton Cancer Center - North | Saint Johnsbury | Vermont |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri |
United States | Saint Louis University Cancer Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Park Nicollet Cancer Center | Saint Louis Park | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
United States | California Pacific Medical Center - California Campus | San Francisco | California |
United States | San Francisco General Hospital Medical Center | San Francisco | California |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Doctors Medical Center - San Pablo Campus | San Pablo | California |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | Shawnee Mission Medical Center | Shawnee Mission | Kansas |
United States | Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta | New Jersey |
United States | Valley Cancer Center | Spring Valley | Illinois |
United States | Cancer Institute at St. John's Hospital | Springfield | Illinois |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Mercy Medical Center | Springfield | Ohio |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Stanford Cancer Center | Stanford | California |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey |
United States | Cotton-O'Neil Cancer Center | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base | California |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Solano Radiation Oncology Center | Vacaville | California |
United States | Sutter Solano Medical Center | Vallejo | California |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek | California |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia |
United States | University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin |
United States | Precision Radiotherapy at University Pointe | West Chester | Ohio |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Wilmed Radiation Oncology Services | Wilson | North Carolina |
United States | Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina |
United States | Cancer Treatment Center | Wooster | Ohio |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States, Canada,
Ang KK, Zhang Q, Rosenthal DI, Nguyen-Tan PF, Sherman EJ, Weber RS, Galvin JM, Bonner JA, Harris J, El-Naggar AK, Gillison ML, Jordan RC, Konski AA, Thorstad WL, Trotti A, Beitler JJ, Garden AS, Spanos WJ, Yom SS, Axelrod RS. Randomized phase III trial of — View Citation
Schwartz DL, Harris J, Yao M, Rosenthal DI, Opanowski A, Levering A, Ang KK, Trotti AM, Garden AS, Jones CU, Harari P, Foote R, Holland J, Zhang Q, Le QT. Metabolic tumor volume as a prognostic imaging-based biomarker for head-and-neck cancer: pilot resul — View Citation
Truong MT, Zhang Q, Rosenthal DI, List M, Axelrod R, Sherman E, Weber R, Nguyen-Tân PF, El-Naggar A, Konski A, Galvin J, Schwartz D, Trotti A, Silverman C, Singh A, Godette K, Bonner JA, Jones CU, Garden AS, Shenouda G, Matthiesen C, Le QT, Bruner D. Qual — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) (3-year Rate Reported) | Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Overall Survival (OS) (3-year Rate Reported) | Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Local-regional Failure (LRF) (3-year Rate Reported) | Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method. | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Rate of Mucositis Toxicity = Grade 3 | Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Rate of Other Toxicity = Grade 3 (Not Mucositis) | Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Rate of Patients Who Tolerated Treatment | A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab . | From start of treatment to end of treatment (6-7 weeks) | |
Secondary | Rate of Deaths = 30 Days After Discontinuation of Protocol Treatment | Patients who died during treatment or within 30 days after the end of treatment | From start of treatment to 30 days after the end of treatment | |
Secondary | Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) | The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). | 3 months and 12 months | |
Secondary | Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores = 50 | The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete. | 3 months and 12 months | |
Secondary | Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months | The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported. | Baseline and 12 months | |
Secondary | Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF | EGFR expression is categorized as high (>/=80%) and low (<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method. | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF | SUVmax is categorized as high (>median) and low ( | From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.) | |
Secondary | 2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response | Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy. | From randomization to 2 years |
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