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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 listopada 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

238

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, Stany Zjednoczone, 36652-2144
        • Mobile Infirmary Medical Center
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85013
        • Arizona Oncology Services Foundation
      • Scottsdale, Arizona, Stany Zjednoczone, 85259-5499
        • Mayo Clinic Scottsdale
      • Scottsdale, Arizona, Stany Zjednoczone, 85260
        • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
      • Scottsdale, Arizona, Stany Zjednoczone, 85251
        • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
    • California
      • Auburn, California, Stany Zjednoczone, 95603
        • Auburn Radiation Oncology
      • Burbank, California, Stany Zjednoczone, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Cameron Park, California, Stany Zjednoczone, 95682
        • Radiation Oncology Centers - Cameron Park
      • Carmichael, California, Stany Zjednoczone, 95608
        • Mercy Cancer Center at Mercy San Juan Medical Center
      • Loma Linda, California, Stany Zjednoczone, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Mission Hills, California, Stany Zjednoczone, 91346-9600
        • Providence Holy Cross Cancer Center
      • Oakland, California, Stany Zjednoczone, 94609
        • CCOP - Bay Area Tumor Institute
      • Roseville, California, Stany Zjednoczone, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Stany Zjednoczone, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Sacramento, California, Stany Zjednoczone, 95819
        • Mercy General Hospital
      • Sacramento, California, Stany Zjednoczone, 95817
        • University of California Davis Cancer Center
      • Torrance, California, Stany Zjednoczone, 90509
        • Torrance Memorial Medical Center
      • Vacaville, California, Stany Zjednoczone, 95687
        • Solano Radiation Oncology Center
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06511
        • Hospital of Saint Raphael
    • Delaware
      • Newark, Delaware, Stany Zjednoczone, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Boca Raton, Florida, Stany Zjednoczone, 33486
        • Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
      • Fort Lauderdale, Florida, Stany Zjednoczone, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Jacksonville, Florida, Stany Zjednoczone, 32224
        • Mayo Clinic - Jacksonville
      • Jacksonville, Florida, Stany Zjednoczone, 32207
        • Baptist Cancer Institute - Jacksonville
      • Jupiter, Florida, Stany Zjednoczone, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami, Florida, Stany Zjednoczone, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami Beach, Florida, Stany Zjednoczone, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, Stany Zjednoczone, 32806
        • M.D. Anderson Cancer Center Orlando
      • Tallahassee, Florida, Stany Zjednoczone, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, Stany Zjednoczone, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Columbus, Georgia, Stany Zjednoczone, 31904
        • John B. Amos Cancer Center
      • Gainesville, Georgia, Stany Zjednoczone, 30501
        • Northeast Georgia Medical Center
      • Savannah, Georgia, Stany Zjednoczone, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Alton, Illinois, Stany Zjednoczone, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Harvey, Illinois, Stany Zjednoczone, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Maywood, Illinois, Stany Zjednoczone, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Mount Vernon, Illinois, Stany Zjednoczone, 62864
        • Good Samaritan Regional Health Center
      • Springfield, Illinois, Stany Zjednoczone, 62702
        • Cancer Institute at St. John's Hospital
    • Indiana
      • Elkhart, Indiana, Stany Zjednoczone, 46515
        • Elkhart General Hospital
      • La Porte, Indiana, Stany Zjednoczone, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend, Indiana, Stany Zjednoczone, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Stany Zjednoczone, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Dubuque, Iowa, Stany Zjednoczone, 52001
        • Wendt Regional Cancer Center at Finley Hospital
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Lexington, Kentucky, Stany Zjednoczone, 40504
        • John D. Cronin Cancer Center
    • Louisiana
      • Alexandria, Louisiana, Stany Zjednoczone, 71315-3198
        • Tulane Cancer Center
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Stany Zjednoczone, 02118
        • Cancer Research Center at Boston Medical Center
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Fall River, Massachusetts, Stany Zjednoczone, 02721
        • Hudner Oncology Center at Saint Anne's Hospital - Fall River
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48106-0995
        • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
      • Detroit, Michigan, Stany Zjednoczone, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Flint, Michigan, Stany Zjednoczone, 48503
        • Hurley Medical Center
      • Flint, Michigan, Stany Zjednoczone, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Stany Zjednoczone, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Stany Zjednoczone, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Kalamazoo, Michigan, Stany Zjednoczone, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Stany Zjednoczone, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, Stany Zjednoczone, 49007-3731
        • West Michigan Cancer Center
      • Marquette, Michigan, Stany Zjednoczone, 49855
        • Upper Michigan Cancer Center at Marquette General Hospital
      • Saint Joseph, Michigan, Stany Zjednoczone, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • Minnesota
      • Burnsville, Minnesota, Stany Zjednoczone, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Stany Zjednoczone, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, Stany Zjednoczone, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Stany Zjednoczone, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • University of Minnesota Medical Center & Children's Hospital - Fairview
      • Minneapolis, Minnesota, Stany Zjednoczone, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Stany Zjednoczone, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Stany Zjednoczone, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Stany Zjednoczone, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
        • Park Nicollet Health Services
      • Saint Paul, Minnesota, Stany Zjednoczone, 55102
        • United Hospital
      • Waconia, Minnesota, Stany Zjednoczone, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Pascagoula, Mississippi, Stany Zjednoczone, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, Stany Zjednoczone, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Cape Girardeau, Missouri, Stany Zjednoczone, 63701
        • Saint Francis Medical Center
      • Kansas City, Missouri, Stany Zjednoczone, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Stany Zjednoczone, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Stany Zjednoczone, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • Springfield, Missouri, Stany Zjednoczone, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Stany Zjednoczone, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nebraska
      • Kearney, Nebraska, Stany Zjednoczone, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Omaha, Nebraska, Stany Zjednoczone, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • New Hampshire
      • Lebanon, New Hampshire, Stany Zjednoczone, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Stany Zjednoczone, 08103
        • Cancer Institute of New Jersey at Cooper University Hospital - Camden
      • East Orange, New Jersey, Stany Zjednoczone, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Marlton, New Jersey, Stany Zjednoczone, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • New Brunswick, New Jersey, Stany Zjednoczone, 08903
        • Saint Peter's University Hospital
      • Toms River, New Jersey, Stany Zjednoczone, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
      • Voorhees, New Jersey, Stany Zjednoczone, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Brooklyn, New York, Stany Zjednoczone, 11201
        • Long Island College Hospital
      • Buffalo, New York, Stany Zjednoczone, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, Stany Zjednoczone, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse, New York, Stany Zjednoczone, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, Stany Zjednoczone, 28801
        • Mission Hospitals - Memorial Campus
      • Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Goldsboro, North Carolina, Stany Zjednoczone, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greenville, North Carolina, Stany Zjednoczone, 27835-6028
        • Leo W. Jenkins Cancer Center at ECU Medical School
      • Statesville, North Carolina, Stany Zjednoczone, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, Stany Zjednoczone, 27103
        • Forsyth Regional Cancer Center at Forsyth Medical Center
    • Ohio
      • Akron, Ohio, Stany Zjednoczone, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Stany Zjednoczone, 44309-2090
        • Akron City Hospital
      • Cincinnati, Ohio, Stany Zjednoczone, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Columbus, Ohio, Stany Zjednoczone, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • Mayfield Heights, Ohio, Stany Zjednoczone, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Abington, Pennsylvania, Stany Zjednoczone, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Stany Zjednoczone, 19010
        • Bryn Mawr Hospital
      • East Stroudsburg, Pennsylvania, Stany Zjednoczone, 18301
        • Dale and Frances Hughes Cancer Center at Pocono Medical Center
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Paoli, Pennsylvania, Stany Zjednoczone, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15219
        • Mercy Cancer Institute at Mercy Hospital
      • Reading, Pennsylvania, Stany Zjednoczone, 19612-6052
        • Reading Hospital and Medical Center
      • Sayre, Pennsylvania, Stany Zjednoczone, 18840
        • Guthrie Cancer Center at Guthrie Clinic Sayre
      • State College, Pennsylvania, Stany Zjednoczone, 16803
        • Mount Nittany Medical Center
      • Wynnewood, Pennsylvania, Stany Zjednoczone, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, Stany Zjednoczone, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Stany Zjednoczone, 17405
        • York Cancer Center at Apple Hill Medical Center
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, Stany Zjednoczone, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Stany Zjednoczone, 29601
        • Bon Secours St. Francis Health System
      • Spartanburg, South Carolina, Stany Zjednoczone, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Stany Zjednoczone, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, Stany Zjednoczone, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Kingsport, Tennessee, Stany Zjednoczone, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, Stany Zjednoczone, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Temple, Texas, Stany Zjednoczone, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Murray, Utah, Stany Zjednoczone, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, Stany Zjednoczone, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Stany Zjednoczone, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Stany Zjednoczone, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Stany Zjednoczone, 84112
        • Huntsman Cancer Institute at University of Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84106
        • Utah Cancer Specialists at UCS Cancer Center
      • Salt Lake City, Utah, Stany Zjednoczone, 84143
        • Latter Day Saints Hospital
    • Virginia
      • Danville, Virginia, Stany Zjednoczone, 24541
        • Danville Regional Medical Center
      • Richmond, Virginia, Stany Zjednoczone, 23249
        • Veterans Affairs Medical Center - Richmond
      • Richmond, Virginia, Stany Zjednoczone, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • Washington
      • Bellingham, Washington, Stany Zjednoczone, 98225
        • St. Joseph Cancer Center
      • Seattle, Washington, Stany Zjednoczone, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Stany Zjednoczone, 98195-6043
        • University Cancer Center at University of Washington Medical Center
    • West Virginia
      • Wheeling, West Virginia, Stany Zjednoczone, 26003
        • Schiffler Cancer Center at Wheeling Hospital
    • Wisconsin
      • Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Stany Zjednoczone, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Stany Zjednoczone, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, Stany Zjednoczone, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • La Crosse, Wisconsin, Stany Zjednoczone, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Stany Zjednoczone, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marinette, Wisconsin, Stany Zjednoczone, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Milwaukee, Wisconsin, Stany Zjednoczone, 53226
        • Medical College of Wisconsin Cancer Center
      • Racine, Wisconsin, Stany Zjednoczone, 53405
        • All Saints Cancer Center at All Saints Healthcare

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
Biologiczny: 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.
Lek: cisplatin
30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
Promieniowanie: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Eksperymentalny: RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
Biologiczny: 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.
Promieniowanie: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Lek: docetaxel
15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disease-free Survival
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.
Local-regional Control
Ramy czasowe: From randomization to 2 years
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).
From randomization to 2 years
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
Ramy czasowe: From randomization to two years
From randomization to two years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Radiation Therapy Oncology Group

Współpracownicy

National Cancer Institute (NCI)
NRG Oncology

Śledczy

  • Główny śledczy: Paul M. Harari, MD, University of Wisconsin, Madison
  • Krzesło do nauki: Jeffrey N. Myers, MD, PhD, FACS, M.D. Anderson Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2004

Zakończenie podstawowe (Rzeczywisty)

1 marca 2009

Ukończenie studiów (Rzeczywisty)

1 grudnia 2016

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2004

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2004

Pierwszy wysłany (Oszacować)

11 czerwca 2004

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 grudnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 listopada 2018

Ostatnia weryfikacja

1 grudnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RTOG-0234
  • CDR0000360850

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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