Full Text View
Tabular View
No Study Results Posted
Related Studies
Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
This study has been completed.
First Received: March 7, 2000   Last Updated: May 9, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004917
  Purpose

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.


Condition Intervention Phase
Anemia
Head and Neck Cancer
Biological: epoetin alfa
Drug: cisplatin
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004917

  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-3657
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
Huntsville Hospital System
Huntsville, Alabama, United States, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
California Cancer Center
Fresno, California, United States, 93720
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Huntington Cancer Center
Pasadena, California, United States, 91105
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1714
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
O'Connor Hospital
San Jose, California, United States, 95128
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Medical Group, Incorporated
San Diego, California, United States, 92101
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, United States, 91767
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Torrance Memorial Medical Center
Torrance, California, United States, 90505
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8040
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
Bay Medical Center
Panama City, Florida, United States, 32401
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806-2134
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Scott and White Hospital
Peoria, Illinois, United States, 61602
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Bloomington Hospital
Bloomington, Indiana, United States, 47402
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Community Regional Cancer Care
Indianapolis, Indiana, United States, 46219
St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0293
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
NSMC Cancer Center
Peabody, Massachusetts, United States, 01960
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
Marquette General Hospital
Marquette, Michigan, United States, 49855
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview University Medical Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
Nebraska Health System
Omaha, Nebraska, United States, 68198-7460
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Medical Center of Princeton
Princeton, New Jersey, United States, 08540
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Beth Israel Medical Center
New York, New York, United States, 10003
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
CCOP - Dayton
Dayton, Ohio, United States, 45429
Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Parma Community General Hospital
Parma, Ohio, United States, 44129
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
St. John Health System
Tulsa, Oklahoma, United States, 74104
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
York Cancer Center
York, Pennsylvania, United States, 17403
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301-3956
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Bayshore Medical Center
Pasadena, Texas, United States, 77504
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05405-0075
United States, Virginia
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Massey Cancer Center
Richmond, Virginia, United States, 23298-0058
Bon Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
All Saints Cancer Center
Racine, Wisconsin, United States, 53405
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Korea, Republic of
Jin Soo Lee Practice Inc.
Gyeonggi, Korea, Republic of, 411-764
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Mitchell Machtay, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Publications:
Machtay M, Pajak TF, Suntharalingam M, Shenouda G, Hershock D, Stripp DC, Cmelak AJ, Schulsinger A, Fu KK. Radiotherapy with or without Erythropoietin for Anemic Patients with Head and Neck Cancer: A Randomized Trial of the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007 Aug 21; [Epub ahead of print]
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.

Study ID Numbers: CDR0000067599, RTOG-9903, RTOG-DEV-1008
Study First Received: March 7, 2000
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00004917     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
anemia

Additional relevant MeSH terms:
Epoetin Alfa
Hematologic Diseases
Antineoplastic Agents
Hematinics
Hematologic Agents
Physiological Effects of Drugs
Anemia
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2009