A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Both
Head and Neck Cancer, Skin Reactions Secondary to Radiation Therapy
Both
Head and Neck Cancer, Skin Reactions Secondary to Radiation Therapy
Trial Information
A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck
OBJECTIVES: I. Compare the efficacy of prophylactic Biafine cream vs standard best
supportive care in reducing grade 2 or higher radiation-induced skin toxicity observed
during radiotherapy in patients with advanced squamous cell carcinoma of the head and neck.
II. Determine if prophylactic or interventional use of Biafine cream is more effective based
on a reduction in maximum skin toxicity resulting from radiation treatment in this patient
population. III. Compare quality of life of these patients with this treatment. IV. Assess
the toxicity of Biafine cream in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to lymph node status
(negative vs positive), type of treatment (radiation plus chemotherapy vs radiation alone),
radiation fractionation (standard vs concurrent boost), and radiation dose (50-60 Gy vs
greater than 60 Gy). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients
receive radiotherapy once daily 5 days a week for 5-8 weeks, with or without standard skin
cream application (no Biafine cream) to irradiated skin. Arm II: Patients receive
radiotherapy as in arm I, with Biafine cream applied to skin 3 times daily 7 days a week at
the initiation of radiotherapy and continuing for 2 weeks after the last radiation
treatment. Biafine cream is applied no fewer than 4 hours before treatment and no fewer than
4 hours between applications. Arm III: Patients receive radiotherapy as in arms I and II,
with Biafine cream applied as in arm II only after skin becomes symptomatic (i.e., redness,
dryness, itching, or tenderness). Quality of life is assessed before treatment, weekly
during treatment, and then weekly for 4 weeks after treatment completion. Patients are
followed weekly for 4 weeks.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 17
months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV squamous cell carcinoma
of the head and neck, including: Oral cavity Oropharyngeal Hypopharyngeal Laryngeal
Radiotherapy indicated as primary treatment or treatment after primary surgical resection
Primary field to receive at least 50 Gy No skin rash, ulceration, or open wound in
treatment field No tumor involvement of the skin
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No known skin allergy or sensitivity to Biafine No inflammatory or
connective tissue disorders of the skin No history of mental incompetence, including
psychological disorders or drug dependency disorders, that would preclude study compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent
chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics No prior radiotherapy to treatment field Surgery: See Disease
Characteristics Prior surgery allowed Other: No other concurrent investigational therapy
No concurrent participation on other RTOG clinical trials No concurrent amifostine
(concurrent pilocarpine allowed)
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Elizabeth Elliott, MRT(T), MRT(R), CCRP
Investigator Role:
Study Chair
Investigator Affiliation:
Margaret and Charles Juravinski Cancer Centre
Authority:
United States: Federal Government
Study ID:
CDR0000068312
NCT ID:
NCT00006481
Start Date:
October 2000
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Skin Reactions Secondary to Radiation Therapy
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- skin reactions secondary to radiation therapy
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| 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 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| 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 |
| 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 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| 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 - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| 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 |
| 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 |
| Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
| 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 |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
| 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 |
| Glendale Memorial Hospital and Health Center | Glendale, California 91204 |
| 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 |
| Lykes Center for Radiation Therapy | Clearwater, Florida 33757-0210 |
| Halifax Medical Center | Daytona Beach, Florida 32114 |
| Radiation Therapy Associates - Fort Myers | Fort Myers, Florida 33901 |
| 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 |
| Florida Radiation Oncology Group | Orange Park, Florida 32073 |
| 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 |
| Clarion Health Partners Inc. | Indianapolis, Indiana 46206-1367 |
| Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis, Indiana 46219 |
| Ball Memorial Hospital | Muncie, Indiana 47303-3499 |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| 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 |
| Romagosa Radiation Oncology Center | Lafayette, Louisiana 70501 |
| 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 |
| Radiation Oncology Affiliates of Maryland, P.A. | Baltimore, Maryland 21237 |
| 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 |
| St. Mary's Medical Center | Saginaw, Michigan 48601 |
| 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 |
| Saint Joseph Medical Center | Albuquerque, New Mexico 87102 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| Finger Lakes Radiation Oncology, P.C. | Clifton Springs, New York 14432 |
| Beth Israel Medical Center | New York, New York 10003 |
| Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| Vassar Brothers Hospital | Poughkeepsie, New York 12601 |
| New York Medical College | Valhalla, New York 10595 |
| Northeast Medical Center | Concord, North Carolina 28025 |
| Catawba Memorial Hospital | Hickory, North Carolina 28601 |
| Meritcare Roger Maris Cancer Center | Fargo, North Dakota 58122 |
| 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 |
| Penn State Geisinger Cancer Center | Hershey, Pennsylvania 17033 |
| 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 |
| Grand View Hospital | Sellersville, Pennsylvania 18960 |
| Wilkes Barre General Hospital | Wilkes-Barre, Pennsylvania 18764 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| 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 |
| Julie and Ben Rogers Cancer Institute | Beaumont, Texas 77701 |
| 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 |
| East Texas Medical Center - Cancer Institute | Tyler, Texas 75701 |
| Dixie Regional Medical Center | Saint George, Utah 84770 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
| Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
| 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 |
| St. Joseph's Hospital | Milwaukee, Wisconsin 53210 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| Southeastern Wisconsin Regional Cancer Center | Racine, Wisconsin 53405 |
| 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 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| 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 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
| Providence Alaska Medical Center | Anchorage, Alaska 99508 |
| 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 |
| Provena St. Joseph Hospital- Regional Cancer Care Center | Elgin, Illinois 60123 |
| Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
| MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| North Mississippi Medical Center/Cancer Center | Tupelo, Mississippi 38801 |
| 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 |
| RMH Regional Canter Center | Harrisonburg, Virginia 22801 |
| Schiffler Cancer Center | Wheeling, West Virginia 26003 |
| Oklahoma University Medical 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 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| William Beaumont Hospital - Troy | Troy, Michigan 48098 |
| Valley Hospital | Ridgewood, New Jersey 07450 |
| Riverhill Radiation Oncology | Yonkers, New York 10701 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| Pocono Cancer Center | East Stroudsburg, Pennsylvania 18301 |
| Bon-Secours - St. Mary's Hospital | Richmond, Virginia 23226 |
| Fitzgerald Mercy Hospital | Darby, Pennsylvania 19023 |
