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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 de noviembre de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

238

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
Biológico: 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.
Droga: cisplatin
30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
Radiación: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Experimental: RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
Biológico: 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.
Radiación: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Droga: docetaxel
15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease-free Survival
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From randomization to two years
From randomization to two years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radiation Therapy Oncology Group

Colaboradores

National Cancer Institute (NCI)
NRG Oncology

Investigadores

  • Investigador principal: Paul M. Harari, MD, University of Wisconsin, Madison
  • Silla de estudio: Jeffrey N. Myers, MD, PhD, FACS, M.D. Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2004

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2004

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2004

Publicado por primera vez (Estimar)

11 de junio de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de diciembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

15 de noviembre de 2018

Última verificación

1 de diciembre de 2016

Más información

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Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RTOG-0234
  • CDR0000360850

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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