Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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. listopadu 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

238

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
Biologický: 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.
Lék: cisplatin
30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.
Záření: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Experimentální: RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
Biologický: 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.
Záření: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Lék: docetaxel
15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Disease-free Survival
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From randomization to two years
From randomization to two years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Radiation Therapy Oncology Group

Spolupracovníci

National Cancer Institute (NCI)
NRG Oncology

Vyšetřovatelé

  • Vrchní vyšetřovatel: Paul M. Harari, MD, University of Wisconsin, Madison
  • Studijní židle: Jeffrey N. Myers, MD, PhD, FACS, M.D. Anderson Cancer Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2004

Primární dokončení (Aktuální)

1. března 2009

Dokončení studie (Aktuální)

1. prosince 2016

Termíny zápisu do studia

První předloženo

10. června 2004

První předloženo, které splnilo kritéria kontroly kvality

10. června 2004

První zveřejněno (Odhad)

11. června 2004

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. prosince 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. listopadu 2018

Naposledy ověřeno

1. prosince 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RTOG-0234
  • CDR0000360850

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit