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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


Phase 3
N/A
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Complications, Radiation Toxicity

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Francis G. LeVeque, DDS

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068406

NCT ID:

NCT00008398

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Oral Complications
  • Radiation Toxicity
  • 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
  • stage III oropharyngeal cancer
  • stage IV oropharyngeal cancer
  • recurrent oropharyngeal cancer
  • oral complications
  • radiation toxicity
  • Head and Neck Neoplasms
  • Radiation Injuries
  • Mucositis

Name

Location

Akron City Hospital Akron, Ohio  44304
Cleveland Clinic Foundation Cleveland, Ohio  44195
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Sylvester Cancer Center, University of Miami Miami, Florida  33136
Hurley Medical Center Flint, Michigan  48503
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Bloomington Hospital Bloomington, Indiana  47402
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Henry Ford Hospital Detroit, Michigan  48202
Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Huntsville Hospital System Huntsville, Alabama  35801
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Radiation Oncology Associates of West Alabama Tuscallosa, Alabama  35401
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Loma Linda University Medical Center Loma Linda, California  92354
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Cancer Care Center Pomona, California  91767
Radiation Oncology Center - Sacramento Sacramento, California  95816
O'Connor Hospital San Jose, California  95128
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
University of Florida Health Science Center Gainesville, Florida  32610-0296
Health First Holmes Regional Medical Center Melbourne, Florida  32901
Baptist Hospital of Miami Miami, Florida  33176-2197
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology Center Sarasota, Florida  34233
Medical Center/John B. Amos Community Cancer Center Columbus, Georgia  31902
Northwest Community Hospital Arlington Heights, Illinois  60005
Northwestern Memorial Hospital Chicago, Illinois  60611
Ingalls Memorial Hospital Harvey, Illinois  60426
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Central Illinois Springfield, Illinois  62526
St. John's Medical Center Anderson, Indiana  46016
Ball Memorial Hospital Muncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louisville Radiation Oncology Louisville, Kentucky  40215
Merle M. Mahr Cancer Center Madisonville, Kentucky  42431
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Tulane University School of Medicine New Orleans, Louisiana  70112
Maine Medical Center Portland, Maine  04102
Anne Arundel Oncology Center Annapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer Center Baltimore, Maryland  21204
Harbor Hospital Center Baltimore, Maryland  21225
Cape Cod Hospital Hyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer Center Flint, Michigan  48432
Marquette General Hospital Marquette, Michigan  49855
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Methodist Cancer Center - Omaha Omaha, Nebraska  68114
Elliot Regional Cancer Center Manchester, New Hampshire  03103
John F. Kennedy Medical Center Edison, New Jersey  08818
Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
New York Methodist Hospital Brooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Vassar Brothers Hospital Poughkeepsie, New York  12601
Northeast Medical Center Concord, North Carolina  28025
Akron General Medical Center Akron, Ohio  44302
Christ Hospital Cincinnati, Ohio  45219
University Hospitals of Cleveland Cleveland, Ohio  44106
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
Lehigh Valley Hospital Allentown, Pennsylvania  18103
St. Luke's Hospital Regional Cancer Center Bethlehem, Pennsylvania  18015
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Philadelphia Philadelphia, Pennsylvania  19104
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Mercy Hospital of Pittsburgh Pittsburgh, Pennsylvania  15219
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Wilkes Barre General Hospital Wilkes-Barre, Pennsylvania  18764
York Hospital York, Pennsylvania  17315
Roger Williams Medical Center/BUSM Providence, Rhode Island  02908-4735
CCOP - Greenville Greenville, South Carolina  29615
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
Wilford Hall - 59th Medical Wing Lackland Air Force Base, Texas  78236-5300
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Dixie Regional Medical Center Saint George, Utah  84770
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Virginia Mason Medical Center Seattle, Washington  98111
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
CCOP - Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Regional Cancer Center Indianapolis, Indiana  46219
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Radiation Medical Group, Inc. San Diego, California  92101-1492
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Bay Medical Center Panama City, Florida  32401
Tallahassee Memorial Healthcare Tallahassee, Florida  32308
Peninsula Regional Medical Center Salisbury, Maryland  21801
MidMichigan Medical Center - Midland Midland, Michigan  48670
William Beaumont Hospital Royal Oak, Michigan  48073
Nebraska Health System Omaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Monmouth Medical Center Long Branch, New Jersey  07740-6395
South Jersey Regional Cancer Center Millville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Atlantic City Medical Center Pomona, New Jersey  08240
Associated Radiologists, P.A. Warren, New Jersey  07059
St. Anthony Hospital Oklahoma City, Oklahoma  73101
St. John Health System Tulsa, Oklahoma  74104
University of Utah Health Sciences Center Salt Lake City, Utah  84132
Schiffler Cancer Center Wheeling, West Virginia  26003
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Sutter Health West Cancer Research Group Greenbrae, California  94904
Huntington Cancer Center Pasadena, California  91105
Saint Mary's Hospital and Medical Center Grand Junction, Colorado  81502-1628
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Clarian Health Partners Inc. Indianapolis, Indiana  46206-1367
Central Baptist Hospital Lexington, Kentucky  40503
William Beaumont Hospital - Troy Troy, Michigan  48098
Valley Hospital Ridgewood, New Jersey  07450
Radiation Oncology Associates of Albuquerque Albuquerque, New Mexico  87109
Finger Lakes Radiation Oncology Center Clifton Springs, New York  14432
Riverhill Radiation Oncology Yonkers, New York  10701
Trinity Cancer Care Center Minot, North Dakota  58701
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Pocono Cancer Center East Stroudsburg, Pennsylvania  18301
Latter Day Saints Hospital Salt Lake City, Utah  84143
RMH Regional Cancer Center Harrisonburg, Virginia  22801
All Saints Cancer Center Racine, Wisconsin  53405
St. Joseph's Regional Health System Stockton, California  95204
Oncology Institute of Greater Lafayette Lafayette, Indiana  47904
Lourdes Regional Cancer Center Binghamton, New York  13905
North Shore Radiation Oncology Setauket, New York  11733
Bon-Secours - St. Mary's Hospital Richmond, Virginia  23226
Edna Williams Cancer Treatment Center Jacksonville, Florida  32207
Lexington Clinic Cancer Center Lexington, Kentucky  40504
Rex Healthcare Raleigh, North Carolina  27607