Head and Neck Cancer Clinical Trial
Official title:
A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck
Verified date | December 2016 |
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 damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2016 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx - Stage I-IV disease - No distant metastases - No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands - No carcinoma in situ without an identifiable invasive component - Plan for radiotherapy in continuous course - Prior surgical exploration with gross residual disease remaining allowed - Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed - Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed) - No severe anemia (i.e., hemoglobin less than 9.0 g/dL) - No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia) - Not entered on other RTOG head and neck protocols PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Stage III/IV patients receiving concurrent cisplatin: - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Stage III/IV patients receiving concurrent cisplatin: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 50 mL/min Cardiovascular: - No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication) - No unstable angina or other poorly controlled cardiac disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy - No active infection requiring IV antibiotics - No unexplained fever - No AIDS or other history of congenital or acquired immunodeficiency - No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer - No known hypersensitivity to mammalian cell-derived products or to human albumin - No acute/subacute illness that would make the need for transfusion likely PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since other prior cytokine therapy (e.g., filgrastim [G-CSF], interleukins, or interferons) - No prior epoetin alfa - No other concurrent cytokine therapy Chemotherapy: - No prior chemotherapy - Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the head and neck Surgery: - See Disease Characteristics Other: - No concurrent amifostine - No concurrent transfusion |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Center - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | CHUS-Hopital Fleurimont | Fleurimont | Quebec |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | McGill University | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador |
Canada | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario |
Canada | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Korea, Republic of | Jin Soo Lee Practice Inc. | Gyeonggi | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Akron City Hospital | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | Radiation Oncology Associates of Albuquerque | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Anne Arundel Oncology Center | Annapolis | Maryland |
United States | Arlington Cancer Center | Arlington | Texas |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Harbor Hospital Center | Baltimore | Maryland |
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | St. Agnes Cancer Center | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Green Mountain Oncology Group | Bennington | Vermont |
United States | St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Bloomington Hospital | Bloomington | Indiana |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Cancer Center at the University of Virginia | Charlottesville | Virginia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Barrett Cancer Center | Cincinnati | Ohio |
United States | Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Finger Lakes Radiation Oncology Center | Clifton Springs | New York |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Mount Diablo Medical Center | Concord | California |
United States | Northeast Medical Center | Concord | North Carolina |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Mercy Fitzgerald Hospital | Darby | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Pocono Cancer Center | East Stroudsburg | Pennsylvania |
United States | St. Elizabeth Medical Center | Edgewood | Kentucky |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | Trinitas Hospital - Jersey Street Campus | Elizabeth | New Jersey |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLaren Regional Cancer Center | Flint | Michigan |
United States | 21st Century Oncology - Fort Myers | Fort Myers | Florida |
United States | California Cancer Center | Fresno | California |
United States | Saint Agnes Cancer Center | Fresno | California |
United States | University of Florida Health Science Center | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Saint Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health Western Division Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | RMH Regional Cancer Center | Harrisonburg | Virginia |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Comprehensive Cancer Institute of Huntsville | Huntsville | Alabama |
United States | Huntsville Hospital System | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Clarian Health Partners Inc. | Indianapolis | Indiana |
United States | Community Regional Cancer Care | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Florida Radiation Oncology Group | Jacksonville | Florida |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Cancer Center at Lexington Clinic | Lexington | Kentucky |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | Louisville Radiation Oncology | Louisville | Kentucky |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Merle M. Mahr Cancer Center | Madisonville | Kentucky |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Marquette General Hospital | Marquette | Michigan |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Holmes Regional Medical Center | Melbourne | Florida |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Veterans Affairs Medical Center - Miami | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MidMichigan Medical Center - Midland | Midland | Michigan |
United States | South Jersey Regional Cancer Center | Millville | New Jersey |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Fairview University Medical Center | Minneapolis | Minnesota |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | Alabama Oncology, LLC | Montgomery | Alabama |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey |
United States | Ball Memorial Hospital | Muncie | Indiana |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Beth Israel Medical Center | New York | New York |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | St. Anthony Hospital | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Methodist Hospital Cancer Center - Omaha | Omaha | Nebraska |
United States | Nebraska Health System | Omaha | Nebraska |
United States | MD Anderson Cancer Center Orlando | Orlando | Florida |
United States | Bay Medical Center | Panama City | Florida |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Parma Community General Hospital | Parma | Ohio |
United States | Bayshore Medical Center | Pasadena | Texas |
United States | Huntington Cancer Center | Pasadena | California |
United States | NSMC Cancer Center | Peabody | Massachusetts |
United States | CCOP - Scott and White Hospital | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Veterans Affairs Medical Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Atlantic City Medical Center | Pomona | New Jersey |
United States | Robert and Beverly Lewis Family Cancer Care Center | Pomona | California |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Maine Medical Center | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Medical Center of Princeton | Princeton | New Jersey |
United States | Roger Williams Medical Center/BUSM | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | All Saints Cancer Center | Racine | Wisconsin |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Bon Secours - St. Mary's Hospital | Richmond | Virginia |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | James P. Wilmot Cancer Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Regional Radiation Oncology Center at Rome | Rome | Georgia |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Radiation Oncology Center - Sacramento | Sacramento | California |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Mallinckrodt Institute of Radiology | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | Latter Day Saints Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | Radiation Medical Group, Incorporated | San Diego | California |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | O'Connor Hospital | San Jose | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | Tallahassee Memorial Healthcare | Tallahassee | Florida |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | Torrance Memorial Medical Center | Torrance | California |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | CCOP - Oklahoma | Tulsa | Oklahoma |
United States | St. John Health System | Tulsa | Oklahoma |
United States | DCH Cancer Treatment Center | Tuscaloosa | Alabama |
United States | Associated Radiologists, P.A. | Warren | New Jersey |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Schiffler Cancer Center | Wheeling | West Virginia |
United States | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Riverhill Radiation Oncology | Yonkers | New York |
United States | York Cancer Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States, Canada, Korea, Republic of,
Machtay M, Pajak T, Suntharalingam M, et al.: Definitive radiotherapy +/- erythropoietin for squamous cell carcinoma of the head and neck: preliminary report of RTOG 99-03. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-5, S132, 2004.
Machtay M, Pajak TF, Suntharalingam M, Shenouda G, Hershock D, Stripp DC, Cmelak AJ, Schulsinger A, Fu KK; Radiation Therapy Oncology Group. Radiotherapy with or without erythropoietin for anemic patients with head and neck cancer: a randomized trial of t — View Citation
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