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