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Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
This study has been completed.
First Received: January 6, 2001   Last Updated: August 19, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008398
  Purpose

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Oral Complications
Radiation Toxicity
Biological: sargramostim
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients

Resource links provided by NLM:


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

Study Start Date: October 2000
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy.
  • Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week (except on days if receiving concurrent cisplatin) beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks.
  • Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on the same schedule as GM-CSF in arm I.

Quality of life is assessed at baseline, and then at 3, 6, and 12 months.

Patients are followed at 3, 6 and 11 months.

PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed head and neck carcinoma with planned external beam radiotherapy to include 50% of oropharynx, oral cavity, or both]
  • Planned external beam radiotherapy of 60-70 Gy total dose to the primary tumor or standard ports for an unknown primary tumor
  • Neck metastases from an unknown primary allowed if radiotherapy planned to at least 50% of the salivary gland at a dose of at least 50 Gy
  • No T1-T2 glottic tumors
  • No residual oral/oropharyngeal injury from prior chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy or idiosyncratic response to sargramostim (GM-CSF)
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy other than cisplatin

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the head and neck

Surgery:

  • Not specified

Other:

  • No concurrent enrollment on other RTOG head and neck studies
  • No concurrent oral care medications (e.g., amifostine, chlorhexidrine gluconate, sucralfate, or benzydamine HCl) during study radiotherapy
  • No concurrent selective oral cavity decontamination (e.g., IB-367) during study radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008398

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Locations
United States, Alabama
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-2801
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
Huntsville Hospital System
Huntsville, Alabama, United States, 35801-4470
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States, 35401
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
Huntington Cancer Center
Pasadena, California, United States, 91105
Cancer Care Center
Pomona, California, United States, 91767
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
California Cancer Center
Fresno, California, United States, 93720
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
O'Connor Hospital
San Jose, California, United States, 95128
St. Joseph's Regional Health System
Stockton, California, United States, 95204
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Radiation Medical Group, Inc.
San Diego, California, United States, 92101-1492
Sutter Health West Cancer Research Group
Greenbrae, California, United States, 94904
UCSF Cancer Center and Cancer Research Institute
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
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Bay Medical Center
Panama City, Florida, United States, 32401
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Edna Williams Cancer Treatment Center
Jacksonville, Florida, United States, 32207
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
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, 32610-0296
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
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, 31902
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
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
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Oncology Institute of Greater Lafayette
Lafayette, Indiana, United States, 47904
Regional Cancer Center
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
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Lexington Clinic Cancer Center
Lexington, Kentucky, United States, 40504
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
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, 21225
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21225
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
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 - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Marquette General Hospital
Marquette, Michigan, United States, 49855
Hurley Medical Center
Flint, Michigan, United States, 48503
Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Regional Cancer Center
Flint, Michigan, United States, 48432
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
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 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
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
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
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, 07018-1095
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
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
North Shore Radiation Oncology
Setauket, New York, United States, 11733
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
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
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Northeast Medical Center
Concord, North Carolina, United States, 28025
Rex Healthcare
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Akron General Medical Center
Akron, Ohio, United States, 44302
Akron City Hospital
Akron, Ohio, United States, 44309
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195-5044
Christ Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
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, 73190
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
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, 18103
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 Regional Cancer Center
Bethlehem, Pennsylvania, United States, 18015
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
York Hospital
York, Pennsylvania, United States, 17315
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
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
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
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
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, 23298-0037
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, 99210-0248
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 - 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
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Waukesha Memorial Hospital
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
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
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
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
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Francis G. LeVeque, DDS Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068406, RTOG-9901, NCI-P00-0177
Study First Received: January 6, 2001
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00008398     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I nasopharyngeal cancer
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
recurrent nasopharyngeal cancer
stage 0 paranasal sinus and nasal cavity cancer
stage 0 nasopharyngeal cancer
stage 0 oropharyngeal cancer
stage 0 laryngeal cancer
stage 0 hypopharyngeal cancer
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
stage 0 lip and oral cavity cancer
stage I lip and oral cavity cancer
stage II lip and oral cavity cancer
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent lip and oral cavity cancer
stage I hypopharyngeal cancer
stage II hypopharyngeal cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent hypopharyngeal cancer
stage I paranasal sinus and nasal cavity cancer
stage II paranasal sinus and nasal cavity cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage I oropharyngeal cancer
stage II oropharyngeal cancer

Additional relevant MeSH terms:
Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on November 27, 2009