AzTrials
AzTrials

AnemiaPhase 3NCT00004917

Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer

A Phase 3 study testing epoetin alfa, cisplatin and radiation therapy in people with Anemia and Head and Neck Cancer, run by Radiation Therapy Oncology Group at 261 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Head and Neck Cancer
What is being tested?
epoetin alfa, cisplatin and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
261 sitesin 3 countries
Study dates
Jun 2000to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

261 sites in 3 countries.

261 sites in 3 countries

United States240 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44304

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Radiation Oncology Associates of Albuquerque

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0010

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21215-1290

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Vermont Cancer Center

    Burlington, Vermont, 05405-0075

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Finger Lakes Radiation Oncology Center

    Clifton Springs, New York, 14432

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Medical Center/John B. Amos Community Cancer Center

    Columbus, Georgia, 31901

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07019

  • Pocono Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Trinitas Hospital - Jersey Street Campus

    Elizabeth, New Jersey, 07201

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLaren Regional Cancer Center

    Flint, Michigan, 48532-3685

  • 21st Century Oncology - Fort Myers

    Fort Myers, Florida, 33901-8082

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0385

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • Saint Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502-1628

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • RMH Regional Cancer Center

    Harrisonburg, Virginia, 22801

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Huntsville Hospital System

    Huntsville, Alabama, 35807

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Clarian Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • Community Regional Cancer Care

    Indianapolis, Indiana, 46219

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301-3956

  • Florida Radiation Oncology Group

    Jacksonville, Florida, 32207

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Cancer Center at Lexington Clinic

    Lexington, Kentucky, 40504

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0293

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1714

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology

    Louisville, Kentucky, 40215

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901-3276

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38103

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33256-2110

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Fairview University Medical Center

    Minneapolis, Minnesota, 55455

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Alabama Oncology, LLC

    Montgomery, Alabama, 36106-3657

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-5671

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8040

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112-2699

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center

    New York, New York, 10003

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • St. Anthony Hospital

    Oklahoma City, Oklahoma, 73101

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Hospital Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • Nebraska Health System

    Omaha, Nebraska, 68198-7460

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806-2134

  • Bay Medical Center

    Panama City, Florida, 32401

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Huntington Cancer Center

    Pasadena, California, 91105

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • NSMC Cancer Center

    Peabody, Massachusetts, 01960

  • CCOP - Scott and White Hospital

    Peoria, Illinois, 61602

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141-3098

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Robert and Beverly Lewis Family Cancer Care Center

    Pomona, California, 91767

  • Atlantic City Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Medical Center of Princeton

    Princeton, New Jersey, 08540

  • Roger Williams Medical Center/BUSM

    Providence, Rhode Island, 02908-4735

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Bon Secours - St. Mary's Hospital

    Richmond, Virginia, 23226

  • Massey Cancer Center

    Richmond, Virginia, 23298-0058

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Radiation Medical Group, Incorporated

    San Diego, California, 92101

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • O'Connor Hospital

    San Jose, California, 95128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Radiation and Medical Oncology Center

    Sarasota, Florida, 34233

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63108

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • DCH Cancer Treatment Center

    Tuscaloosa, Alabama, 35401

  • Associated Radiologists, P.A.

    Warren Township, New Jersey, 07059

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Wilkes Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Riverhill Radiation Oncology

    Yonkers, New York, 10701

  • York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada20 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

South Korea1 site

  • Jin Soo Lee Practice Inc.

    Gyeonggi-do, 411-764

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
epoetin alfa, cisplatin, radiation therapy
Keywords
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
Medical subject headings
Anemia, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epoetin alfaBiological

  • cisplatinDrug

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2000
  3. Primary completionNov 2007
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004917
Sponsor's protocol ID
RTOG-9903
Other IDs
CDR0000067599
Status last verified
Dec 2016
First submitted
7 Mar 2000
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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 the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1008-17. doi: 10.1016/j.ijrobp.2007.04.063. Epub 2007 Aug 23.

    PubMed 17716826

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epoetin alfa, cisplatin and radiation therapy in people with Anemia and Head and Neck Cancer, run by Radiation Therapy Oncology Group at 261 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in United States, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004917, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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