Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

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

Sponsoren

Hauptsponsor: Radiation Therapy Oncology Group

Mitarbeiter: National Cancer Institute (NCI)

Quelle Radiation Therapy Oncology Group
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum October 2000
Primäres Abschlussdatum March 2004
Phase Phase 3
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Biological

Interventionsname: sargramostim

Interventionsart: Procedure

Interventionsname: quality-of-life assessment

Interventionsart: Radiation

Interventionsname: radiation therapy

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: N/A

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Francis G. LeVeque, DDS Study Chair Barbara Ann Karmanos Cancer Institute
Ort
Einrichtung:
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama, 35294-3300, United States
Huntsville Hospital System | Huntsville, Alabama, 35801-4470, United States
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama, 35801, United States
MBCCOP - Gulf Coast | Mobile, Alabama, 36688, United States
Alabama Oncology, LLC | Montgomery, Alabama, 36106-2801, United States
Radiation Oncology Associates of West Alabama | Tuscaloosa, Alabama, 35401, United States
Foundation for Cancer Research and Education | Phoenix, Arizona, 85013, United States
Mount Diablo Medical Center | Concord, California, 94524-4110, United States
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California, 91010-3000, United States
California Cancer Center | Fresno, California, 93720, United States
Saint Agnes Cancer Center | Fresno, California, 93720, United States
Sutter Health West Cancer Research Group | Greenbrae, California, 94904, United States
Loma Linda University Medical Center | Loma Linda, California, 92354, United States
Veterans Affairs Medical Center - Long Beach | Long Beach, California, 90822, United States
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California, 90095-1781, United States
CCOP - Bay Area Tumor Institute | Oakland, California, 94609-3305, United States
Huntington Cancer Center | Pasadena, California, 91105, United States
Cancer Care Center | Pomona, California, 91767, United States
Radiation Oncology Center - Sacramento | Sacramento, California, 95816, United States
Radiation Medical Group, Inc. | San Diego, California, 92101-1492, United States
UCSF Cancer Center and Cancer Research Institute | San Francisco, California, 94143-0128, United States
O'Connor Hospital | San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California, 95403, United States
St. Joseph's Regional Health System | Stockton, California, 95204, United States
David Grant Medical Center | Travis Air Force Base, California, 94535, United States
Memorial Hospital Cancer Center | Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center | Denver, Colorado, 80010, United States
Saint Mary's Hospital and Medical Center | Grand Junction, Colorado, 81502, United States
CCOP - Christiana Care Health Services | Wilmington, Delaware, 19899, United States
University of Florida Health Science Center | Gainesville, Florida, 32610-0296, United States
Edna Williams Cancer Treatment Center | Jacksonville, Florida, 32207, United States
Health First Holmes Regional Medical Center | Melbourne, Florida, 32901, United States
CCOP - Mount Sinai Medical Center | Miami Beach, Florida, 33140, United States
Veterans Affairs Medical Center - Miami | Miami, Florida, 33125, United States
Sylvester Cancer Center, University of Miami | Miami, Florida, 33136, United States
Baptist Hospital of Miami | Miami, Florida, 33176-2197, United States
MD Anderson Cancer Center Orlando | Orlando, Florida, 32806, United States
Bay Medical Center | Panama City, Florida, 32401, United States
Gulf Coast Cancer Treatment Center | Panama City, Florida, 32405-4587, United States
Sarasota Radiation and Medical Oncology Center | Sarasota, Florida, 34233, United States
Tallahassee Memorial Healthcare | Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida, 33612-9497, United States
Emory University Hospital - Atlanta | Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional | Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia, 31902, United States
Regional Radiation Oncology Center at Rome | Rome, Georgia, 30165, United States
MBCCOP - Hawaii | Honolulu, Hawaii, 96813, United States
Northwest Community Hospital | Arlington Heights, Illinois, 60005, United States
Northwestern Memorial Hospital | Chicago, Illinois, 60611, United States
CCOP - Central Illinois | Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital | Harvey, Illinois, 60426, United States
Loyola University Medical Center | Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center | Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois | Peoria, Illinois, 61636, United States
St. John's Medical Center | Anderson, Indiana, 46016, United States
Bloomington Hospital | Bloomington, Indiana, 47402, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana, 46202, United States
Clarian Health Partners Inc. | Indianapolis, Indiana, 46206-1367, United States
Regional Cancer Center | Indianapolis, Indiana, 46219, United States
Oncology Institute of Greater Lafayette | Lafayette, Indiana, 47904, United States
Ball Memorial Hospital | Muncie, Indiana, 47303-3499, United States
CCOP - Northern Indiana CR Consortium | South Bend, Indiana, 46601, United States
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa, 52001, United States
Central Baptist Hospital | Lexington, Kentucky, 40503, United States
Lexington Clinic Cancer Center | Lexington, Kentucky, 40504, United States
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky, 40536-0084, United States
James Graham Brown Cancer Center | Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology | Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center | Madisonville, Kentucky, 42431, United States
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine | New Orleans, Louisiana, 70112, United States
CCOP - Ochsner | New Orleans, Louisiana, 70121, United States
Maine Medical Center | Portland, Maine, 04102, United States
Anne Arundel Oncology Center | Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland, 21204, United States
Harbor Hospital Center | Baltimore, Maryland, 21225, United States
Sinai Hospital of Baltimore | Baltimore, Maryland, 21225, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland, 21231-2410, United States
Peninsula Regional Medical Center | Salisbury, Maryland, 21801, United States
Cape Cod Hospital | Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts, 02130, United States
CCOP - Ann Arbor Regional | Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109-0752, United States
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201-1379, United States
Henry Ford Hospital | Detroit, Michigan, 48202, United States
McLaren Regional Cancer Center | Flint, Michigan, 48432, United States
Hurley Medical Center | Flint, Michigan, 48503, United States
CCOP - Kalamazoo | Kalamazoo, Michigan, 49007-3731, United States
Marquette General Hospital | Marquette, Michigan, 49855, United States
MidMichigan Medical Center - Midland | Midland, Michigan, 48670, United States
William Beaumont Hospital | Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy | Troy, Michigan, 48098, United States
Mayo Clinic Cancer Center | Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, 55416, United States
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri, 65203, United States
CCOP - Kansas City | Kansas City, Missouri, 64131, United States
Mallinckrodt Institute of Radiology | Saint Louis, Missouri, 63108, United States
St. Louis University Health Sciences Center | Saint Louis, Missouri, 63110-0250, United States
Cancer Research for the Ozarks | Springfield, Missouri, 65807, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium | Billings, Montana, 59101, United States
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska, 68106, United States
Methodist Cancer Center - Omaha | Omaha, Nebraska, 68114, United States
Nebraska Health System | Omaha, Nebraska, 68198-7460, United States
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center | Lebanon, New Hampshire, 03756-0002, United States
Elliot Regional Cancer Center | Manchester, New Hampshire, 03103, United States
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey, 07018-1095, United States
John F. Kennedy Medical Center | Edison, New Jersey, 08818, United States
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey, 07201, United States
Monmouth Medical Center | Long Branch, New Jersey, 07740-6395, United States
South Jersey Regional Cancer Center | Millville, New Jersey, 08332, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey | New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center | Newark, New Jersey, 07112, United States
Atlantic City Medical Center | Pomona, New Jersey, 08240, United States
Valley Hospital | Ridgewood, New Jersey, 07450, United States
Community Medical Center | Toms River, New Jersey, 08755, United States
St. Francis Medical Center | Trenton, New Jersey, 08629, United States
Associated Radiologists, P.A. | Warren, New Jersey, 07059, United States
Radiation Oncology Associates of Albuquerque | Albuquerque, New Mexico, 87109, United States
Cancer Center of Albany Medical Center | Albany, New York, 12208, United States
Lourdes Regional Cancer Center | Binghamton, New York, 13905, United States
State University of New York Health Science Center at Brooklyn | Brooklyn, New York, 11203, United States
New York Methodist Hospital | Brooklyn, New York, 11215-3609, United States
Finger Lakes Radiation Oncology Center | Clifton Springs, New York, 14432, United States
CCOP - North Shore University Hospital | Manhasset, New York, 11030, United States
Memorial Sloan-Kettering Cancer Center | New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States
Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York, 12901, United States
Vassar Brothers Hospital | Poughkeepsie, New York, 12601, United States
University of Rochester Cancer Center | Rochester, New York, 14642, United States
North Shore Radiation Oncology | Setauket, New York, 11733, United States
State University of New York - Upstate Medical University | Syracuse, New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York, 13217, United States
Riverhill Radiation Oncology | Yonkers, New York, 10701, United States
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina, 27599-7295, United States
Northeast Medical Center | Concord, North Carolina, 28025, United States
East Carolina University School of Medicine | Greenville, North Carolina, 27858-4354, United States
Rex Healthcare | Raleigh, North Carolina, 27607, United States
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina, 27157-1082, United States
Trinity Cancer Care Center | Minot, North Dakota, 58701, United States
Akron General Medical Center | Akron, Ohio, 44302, United States
Akron City Hospital | Akron, Ohio, 44309, United States
Christ Hospital | Cincinnati, Ohio, 45219, United States
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio, 45267-0502, United States
Ireland Cancer Center | Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland | Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195-5044, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
CCOP - Columbus | Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio, 43210-1240, United States
CCOP - Dayton | Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio, 43623-3456, United States
St. Anthony Hospital | Oklahoma City, Oklahoma, 73101, United States
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73190, United States
St. John Health System | Tulsa, Oklahoma, 74104, United States
CCOP - Columbia River Program | Portland, Oregon, 97213, United States
Lehigh Valley Hospital | Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital Regional Cancer Center | Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center | Danville, Pennsylvania, 17822-2001, United States
Mercy Fitzgerald Hospital | Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania, 19026, United States
Pocono Cancer Center | East Stroudsburg, Pennsylvania, 18301, United States
Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033-0850, United States
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania, 19104-4283, United States
Veterans Affairs Medical Center - Philadelphia | Philadelphia, Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Cancer Center | Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, 15213-3489, United States
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania, 15224, United States
Reading Hospital and Medical Center | Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania, 18501, United States
Wilkes Barre General Hospital | Wilkes-Barre, Pennsylvania, 18764, United States
York Hospital | York, Pennsylvania, 17315, United States
Roger Williams Medical Center/BUSM | Providence, Rhode Island, 02908-4735, United States
CCOP - Greenville | Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina | Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital | Rapid City, South Dakota, 57709, United States
Jackson-Madison County General Hospital | Jackson, Tennessee, 38301, United States
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee, 38103, United States
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee, 37232-6838, United States
Harrington Cancer Center | Amarillo, Texas, 79106, United States
University of Texas Medical Branch | Galveston, Texas, 77555-0209, United States
University of Texas - MD Anderson Cancer Center | Houston, Texas, 77030-4009, United States
Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas, 78236-5300, United States
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas, 79410-1894, United States
Dixie Regional Medical Center | Saint George, Utah, 84770, United States
University of Utah Health Sciences Center | Salt Lake City, Utah, 84132, United States
Latter Day Saints Hospital | Salt Lake City, Utah, 84143, United States
Vermont Cancer Center | Burlington, Vermont, 05401-3498, United States
Cancer Center at the University of Virginia | Charlottesville, Virginia, 22908, United States
RMH Regional Cancer Center | Harrisonburg, Virginia, 22801, United States
Naval Medical Center, Portsmouth | Portsmouth, Virginia, 23708-2197, United States
Bon-Secours - St. Mary's Hospital | Richmond, Virginia, 23226, United States
Massey Cancer Center | Richmond, Virginia, 23298-0037, United States
Virginia Mason Medical Center | Seattle, Washington, 98111, United States
Deaconess Medical Center | Spokane, Washington, 99210-0248, United States
Yakima Valley Memorial Hospital | Yakima, Washington, 98902, United States
Schiffler Cancer Center | Wheeling, West Virginia, 26003, United States
CCOP - Green Bay | Green Bay, Wisconsin, 54301, United States
St. Vincent Hospital | Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Medical Foundation | La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center | Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin, 53792-6164, United States
Marshfield Clinic | Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital | Menomonee Falls, Wisconsin, 53051, United States
Columbia Hospital | Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center | Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States
All Saints Cancer Center | Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital | Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Center - Calgary | Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada
Saint John Regional Hospital | Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation | St. Johns, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre | Halifax, Nova Scotia, B3H 1V7, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre | Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre | London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre | Ottawa, Ontario, K1H 1C4, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury, Ontario, P3E 5J1, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay, Ontario, P7A 7T1, Canada
Toronto Sunnybrook Regional Cancer Centre | Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital | Toronto, Ontario, M5G 2M9, Canada
CHUS-Hopital Fleurimont | Fleurimont, Quebec, J1H 5N4, Canada
Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, H2L-4M1, Canada
McGill University | Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec | Quebec City, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre | Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre | Saskatoon, Saskatchewan, S7N 4H4, Canada
Standort Länder

Canada

United States

Überprüfungsdatum

November 2013

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Supportive Care

Maskierung: Double

Quelle: ClinicalTrials.gov