Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 novembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

238

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: RT + cisplatin + cetuximab
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
Biologico: 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.
Radiazione: radiation therapy
60 Gy (2 Gy once a day, 5 times a week)
Sperimentale: RT + docetaxel + cetuximab
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
Biologico: 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.
Radiazione: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease-free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From randomization to two years
From randomization to two years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Radiation Therapy Oncology Group

Collaboratori

National Cancer Institute (NCI)
NRG Oncology

Investigatori

  • Investigatore principale: Paul M. Harari, MD, University of Wisconsin, Madison
  • Cattedra di studio: Jeffrey N. Myers, MD, PhD, FACS, M.D. Anderson Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2004

Completamento primario (Effettivo)

1 marzo 2009

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

10 giugno 2004

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2004

Primo Inserito (Stima)

11 giugno 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 dicembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 novembre 2018

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RTOG-0234
  • CDR0000360850

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi