A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
OBJECTIVES:
Primary
- Compare overall survival of patients with stage III or IV squamous cell carcinoma of
the head and neck treated with conventional vs accelerated radiotherapy and concurrent
cisplatin with or without surgical resection.
Secondary
- Compare local-regional control of disease and disease-free rates in patients treated
with these regimens.
- Compare the acute and late toxicity of these regimens in these patients.
- Compare quality of life, perception of side effects, and performance status of patients
treated with these regimens.
- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions
are independent prognostic markers in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod
performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks.
Patients also receive cisplatin IV on days 1, 22, and 43.
- Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5
weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive
cisplatin IV on days 1 and 22.
Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy
undergo surgical resection of the primary tumor.
Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3
and 12 months, and then annually for 4 years.
Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.
PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx
- Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
- No metastases below the clavicle or more distant by clinical exam or radiology
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2
times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 50 mL/min
- Calcium normal
Cardiovascular
- No symptomatic coronary artery disease (angina)
- No myocardial infarction within the past 6 months
Other
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
- No simultaneous primary tumors
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the head and neck except radioactive iodine therapy
Surgery
- No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal
sampling of neck disease
- No radical or modified neck dissection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.
Safety Issue:
No
Principal Investigator
K. Kian Ang, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
RTOG 0129
NCT ID:
NCT00047008
Start Date:
July 2002
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the oropharynx
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| St. Rita's Medical Center | Lima, Ohio 45801 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| Community Medical Center | Toms River, New Jersey 08755 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
| Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| Dixie Regional Medical Center | Saint George, Utah 84770 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Naval Medical Center - San Diego | San Diego, California 92134-3202 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
| Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| 21st Century Oncology - Fort Myers | Fort Myers, Florida 33901-8082 |
| Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Cottonwood Hospital Medical Center | Murray, Utah 84107 |
| McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Summit Medical Center | Oakland, California 94609 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Saint Rose Hospital | Hayward, California 94545 |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California 94806 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| St. Francis Hospital | Wilmington, Delaware 19805 |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
| Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
| Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70140-1015 |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
| Valley Memorial Hospital | Livermore, California 94550 |
| Providence Holy Cross Cancer Center | Mission Hills, California 91346-9600 |
| Highland General Hospital | Oakland, California 94602 |
| Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| Radiological Associates of Sacramento Medical Group, Inc. | Sacramento, California 95815 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
| Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove, Illinois 60515 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth, Indiana 46544 |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
| Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green, Kentucky 42101 |
| Tulane Cancer Center | New Orleans, Louisiana 70112 |
| Hudner Oncology Center at Saint Anne's Hospital | Fall River, Massachusetts 02721 |
| South Suburban Oncology Center | Quincy, Massachusetts 02169 |
| Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint, Michigan 48532 |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada 89502 |
| South Jersey Healthcare Regional Cancer Center | Millville, New Jersey 08332 |
| Randolph Hospital | Asheboro, North Carolina 27203 |
| John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden, North Carolina 27288 |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
| Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
| Akron City Hospital at Summa Health System | Akron, Ohio 44304 |
| Miami Valley Hospital | Dayton, Ohio 45409 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| LaFortune Cancer Center at St. John Health System | Tulsa, Oklahoma 74104 |
| Cancer Center at Paoli Memorial Hospital | Paoli, Pennsylvania 19301 |
| St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
| All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood, California 90301 |
| St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Rappahannock General Hospital | Kilmarnock, Virginia 22482 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale, Arizona 85251 |
| Alexian Brothers Cancer Care Center | Elk Grove Village, Illinois 60007 |
| John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| Washington Hematology - Oncology Specialists | Yakima, Washington 98902 |
| North Star Lodge Cancer Center | Yakima, Washington 98902 |
| Mount Sinai Hospital Medical Center | Chicago, Illinois 60608 |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
| Shands Cancer Center at the University of Florida - Jacksonville | Gainesville, Florida 32610 |
| Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
| New Orleans Cancer Institute at Memorial Medical Center | New Orleans, Louisiana 70115 |
| Cancer Institute of Cape Girardeau | Cape Girardeau, Missouri 63703 |
| Community Memorial Health Center | South Hill, Virginia 23970-0090 |
| Holy Family Memorial Medical Center | Manitowoc, Wisconsin 54221 |
| St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus | Milwaukee, Wisconsin 53211 |
