Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
15. november 2018 opdateret af: Radiation Therapy Oncology Group
A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin.
Secondary
- Compare the safety and efficacy of these regimens in these patients.
- Compare locoregional control and overall survival rates in patients treated with these regimens.
- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2 positive nodes or extracapsular nodal extension]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
238
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Forenede Stater, 36652-2144
- Mobile Infirmary Medical Center
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Arizona
-
Phoenix, Arizona, Forenede Stater, 85013
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, Forenede Stater, 85259-5499
- Mayo Clinic Scottsdale
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Scottsdale, Arizona, Forenede Stater, 85260
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
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Scottsdale, Arizona, Forenede Stater, 85251
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
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California
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Auburn, California, Forenede Stater, 95603
- Auburn Radiation Oncology
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center - Burbank
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Cameron Park, California, Forenede Stater, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Mission Hills, California, Forenede Stater, 91346-9600
- Providence Holy Cross Cancer Center
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Roseville, California, Forenede Stater, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Forenede Stater, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Torrance, California, Forenede Stater, 90509
- Torrance Memorial Medical Center
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Vacaville, California, Forenede Stater, 95687
- Solano Radiation Oncology Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Hospital of Saint Raphael
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Jacksonville
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute - Jacksonville
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Jupiter, Florida, Forenede Stater, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Forenede Stater, 32806
- M.D. Anderson Cancer Center Orlando
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial Hospital
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Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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Georgia
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Columbus, Georgia, Forenede Stater, 31904
- John B. Amos Cancer Center
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Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Illinois
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Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Mount Vernon, Illinois, Forenede Stater, 62864
- Good Samaritan Regional Health Center
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Springfield, Illinois, Forenede Stater, 62702
- Cancer Institute at St. John's Hospital
-
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Indiana
-
Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
-
La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
-
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Iowa
-
Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center at Finley Hospital
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Lexington, Kentucky, Forenede Stater, 40504
- John D. Cronin Cancer Center
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Louisiana
-
Alexandria, Louisiana, Forenede Stater, 71315-3198
- Tulane Cancer Center
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Maryland
-
Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
-
Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Fall River, Massachusetts, Forenede Stater, 02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
-
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Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Marquette, Michigan, Forenede Stater, 49855
- Upper Michigan Cancer Center at Marquette General Hospital
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Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Medical Center & Children's Hospital - Fairview
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Health Services
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Mississippi
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Pascagoula, Mississippi, Forenede Stater, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Cape Girardeau, Missouri, Forenede Stater, 63701
- Saint Francis Medical Center
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Saint Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center at Methodist Hospital - Omaha
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
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East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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New Brunswick, New Jersey, Forenede Stater, 08903
- Saint Peter's University Hospital
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Toms River, New Jersey, Forenede Stater, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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Voorhees, New Jersey, Forenede Stater, 08043
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
-
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New York
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Brooklyn, New York, Forenede Stater, 11201
- Long Island College Hospital
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospitals - Memorial Campus
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Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
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Greenville, North Carolina, Forenede Stater, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Statesville, North Carolina, Forenede Stater, 28677
- Iredell Memorial Hospital
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Forsyth Regional Cancer Center at Forsyth Medical Center
-
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Ohio
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Akron, Ohio, Forenede Stater, 44307
- McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, Forenede Stater, 44309-2090
- Akron City Hospital
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Cincinnati, Ohio, Forenede Stater, 45267
- Charles M. Barrett Cancer Center at University Hospital
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Oregon
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Portland, Oregon, Forenede Stater, 97239-3098
- Oregon Health & Science University Cancer Institute
-
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Paoli, Pennsylvania, Forenede Stater, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Cancer Institute at Mercy Hospital
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Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
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Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
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State College, Pennsylvania, Forenede Stater, 16803
- Mount Nittany Medical Center
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Cancer Center at Lankenau Hospital
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York, Pennsylvania, Forenede Stater, 17405
- York Cancer Center at Apple Hill Medical Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Greenville, South Carolina, Forenede Stater, 29601
- Bon Secours St. Francis Health System
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Forenede Stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
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Texas
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Houston, Texas, Forenede Stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Murray, Utah, Forenede Stater, 84107
- Cottonwood Hospital Medical Center
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Ogden, Utah, Forenede Stater, 84403
- McKay-Dee Hospital Center
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Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Salt Lake City, Utah, Forenede Stater, 84143
- Latter Day Saints Hospital
-
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Virginia
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Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
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Richmond, Virginia, Forenede Stater, 23249
- Veterans Affairs Medical Center - Richmond
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Richmond, Virginia, Forenede Stater, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
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West Virginia
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Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center at Wheeling Hospital
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin Cancer Center
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Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at All Saints Healthcare
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria:
- Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)
Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:
- Histologic extracapsular nodal extension
- Histologic involvement of ≥ 2 regional lymph nodes
- Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.
- Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed
- American Joint Committee on Cancer (AJCC) pathological stage III or IV
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.0 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:
- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
Renal
- Creatinine ≤ 1.5 mg/dL
Cardiovascular
- No unstable angina
- No uncontrolled hypertension
- No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)
- No uncontrolled arrhythmia
- No congestive heart failure
- No more than 2 heart-related hospitalizations within the past year
- No other active cardiac disease
Pulmonary
- No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year
Neurologic
- No pre-existing peripheral neuropathy ≥ grade 2
- No uncontrolled seizure disorder
- No active neurological disease
Other
- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anti-epidermal growth factor receptor antibody therapy
Chemotherapy
- More than 3 years since prior cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior head and neck radiotherapy
Surgery
- See Disease Characteristics
Other
- No prior tyrosine kinase inhibitor therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
|
400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
60 Gy (2 Gy once a day, 5 times a week)
|
|
Eksperimentel: RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
|
400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.
60 Gy (2 Gy once a day, 5 times a week)
15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-free Survival
Tidsramme: From randomization to 2 years
|
Two-year rates are shown (Kaplan-Meier estimates).
Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored).
Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible.
A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.
|
From randomization to 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: From randomization to 2 years
|
Two-year rates are shown (Kaplan-Meier estimates).
Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).
|
From randomization to 2 years
|
|
Treatment Tolerance
Tidsramme: From start of treatment to end of treatment (protocol treatment lasts seven weeks).
|
Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription.
The percentage of patients determined to be tolerant of treatment are shown.
|
From start of treatment to end of treatment (protocol treatment lasts seven weeks).
|
|
Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)
Tidsramme: From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
|
Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity).
The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%.
The unacceptable rate was >30%.
[RTOG = Radiation Therapy Oncology Group]
|
From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
|
|
Frequency of Other Acute and Late Toxicity
Tidsramme: From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
|
Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.
|
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
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Local-regional Control
Tidsramme: From randomization to 2 years
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Two-year rate is shown (cumulative incidence estimate).
Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
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From randomization to 2 years
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Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival
Tidsramme: From randomization to two years
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From randomization to two years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paul M. Harari, MD, University of Wisconsin, Madison
- Studiestol: Jeffrey N. Myers, MD, PhD, FACS, M.D. Anderson Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Harari PM, Harris J, Kies MS, et al.: Phase II randomized trial of surgery followed by chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-22, S13, 2007.
- Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K. Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol. 2014 Aug 10;32(23):2486-95. doi: 10.1200/JCO.2013.53.9163. Epub 2014 Jul 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2004
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
10. juni 2004
Først indsendt, der opfyldte QC-kriterier
10. juni 2004
Først opslået (Skøn)
11. juni 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2018
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III planocellulært karcinom i oropharynx
- stadium III lymfepitheliom i oropharynx
- stadium IV planocellulært karcinom i oropharynx
- stadium IV lymfepitheliom i oropharynx
- stadium III planocellulært karcinom i hypopharynx
- stadium IV planocellulært karcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- stadium IV planocellulært karcinom i strubehovedet
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, pladecelle
- Karcinom
- Karcinom, pladecelle
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, immunologiske
- Docetaxel
- Cisplatin
- Cetuximab
Andre undersøgelses-id-numre
- RTOG-0234
- CDR0000360850
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med cetuximab
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University Medical Center GroningenUMC Utrecht; Erasmus Medical CenterRekrutteringPlanocellulært karcinom i hoved og hals | MarginvurderingHolland
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Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center GroningenAfsluttetMetastatisk tyktarmskræftHolland
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West China HospitalFirst Affiliated Hospital of Chongqing Medical UniversityRekrutteringColo-rektal cancer | Capecitabin | CetuximabKina
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Eben RosenthalNational Cancer Institute (NCI)AfsluttetAdenocarcinom i bugspytkirtlenForenede Stater
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HiberCell, Inc.AfsluttetKolorektal cancerForenede Stater, Puerto Rico, Tyskland, Frankrig
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Merck KGaA, Darmstadt, GermanyAfsluttetTidligere ubehandlet metastatisk tyktarmskræftFrankrig, Italien, Polen, Tyskland, Hong Kong, Østrig, Brasilien, Israel, Grækenland, Argentina, Thailand, Belgien, Australien, Mexico
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Gruppo Oncologico del Nord-OvestAfsluttetMetastatisk tyktarmskræftItalien
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Cancer Institute and Hospital, Chinese Academy...Rekruttering
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Poitiers University HospitalAfsluttetUndersøgelse af hudtoksicitet af Cetuximab: Find en forbindelse mellem hudbetændelse og tumorresponsMetastatisk tyktarmskræftFrankrig
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Copenhagen University Hospital at HerlevUkendt