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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004917
Other study ID # RTOG-9903
Secondary ID CDR0000067599
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2000
Est. completion date December 2016

Study information

Verified date December 2016
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

OBJECTIVES: Primary - Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck. Secondary - Determine whether this drug improves survival in this patient population. - Identify patterns in first failure in these patients. - Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients. - Assess the toxicity of this regimen in these patients. OUTLINE: This is a randomized study. Patients are stratified according to stage (I/II vs III/IV without chemotherapy vs III/IV with chemotherapy), pretreatment hemoglobin level (9.0 to less than 11.5 g/dL vs 11.5 to 13.5 g/dL), and gender. Patients are randomized to one of two treatment arms. - Arm I: Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks. Patients with stage III or IV disease undergo radiotherapy once daily for 3.5 weeks and then twice daily (6 hours apart) for 2.5 weeks for a total of 6 weeks. - Arm II: Patients undergo radiotherapy as in arm I. Beginning 7-10 days before radiotherapy, patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy. Patients with stage III/IV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 372 patients (186 per arm) will be accrued for this study within 3.5 years.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
epoetin alfa

Drug:
cisplatin

Radiation:
radiation therapy


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

References & Publications (2)

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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