Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Test af Docetaxel-Cetuximab eller tilføjelsen af ​​et immunterapilægemiddel, Atezolizumab, til den sædvanlige kemoterapi og strålebehandling ved højrisiko hoved- og halskræft

11. november 2026 opdateret af: National Cancer Institute (NCI)

Randomiseret fase II/III-forsøg med adjuverende strålebehandling med cisplatin, docetaxel-cetuximab eller cisplatin-atezolizumab ved patologisk højrisiko pladecellekræft i hoved og nakke

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Suspenderet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) (COMPLETE AS OF 20-MAR-2020) II. To determine if the combination of docetaxel-cetuximab and intensity-modulated radiation therapy (IMRT) is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). (Phase III) III. To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC. (Phase III)

SECONDARY OBJECTIVES:

I. To compare disease-free survival (DFS) between each experimental arm and the control arm. (Phase III) II. To determine whether each experimental arm improves local-regional disease control and the rate of distant metastasis. (Phase III) III. To compare acute toxicity profiles between each experimental arm and the control arm. (Phase III) IV. To compare late toxicity profiles at 1, 3, and 5 years after treatment. (Phase III) V. To assess long term DFS and OS between each experimental arm and the control arm. (Phase III) VI. To compare symptom burden, as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) (primary patient reported outcome [PRO]), and quality of life, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) (secondary PRO), between each experimental arm and the control arm. (Phase III)

EXPLORATORY OBJECTIVE:

I. To collect blood and tissue specimens for future translational research. (Phase III)

OUTLINE: Patients are randomized to 1 of 3 arms - Phase II (Arms 1, 2 or 3) and for Phase III (Arms 1, 3 or 4).

ARM 1: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks and receive concurrent cisplatin intravenously (IV) over 1-2 hours once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. (CLOSED AS OF 20-MAR-2020)

ARM 3: Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and concurrently receive docetaxel once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM 4: Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity.

All patients undergo collection of blood samples during screening and throughout the study and may undergo computed tomography (CT) scans and/or magnetic resonance imaging (MRI) and biopsy as clinically indicated on study.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
613

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
      • Birmingham, Alabama, Forenede Stater, 35243
        • The Kirklin Clinic at Acton Road
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Forenede Stater, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Auburn, California, Forenede Stater, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Burbank, California, Forenede Stater, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Cameron Park, California, Forenede Stater, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Carmichael, California, Forenede Stater, 95608
        • Mercy San Juan Medical Center
      • Encinitas, California, Forenede Stater, 92024
        • UC San Diego Health System - Encinitas
      • La Jolla, California, Forenede Stater, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Medical Center
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Cancer Institute Palo Alto
      • Roseville, California, Forenede Stater, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Forenede Stater, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Medical Center-Mount Zion
      • San Mateo, California, Forenede Stater, 94401
        • Mills Health Center
      • St. Helena, California, Forenede Stater, 94574
        • Saint Helena Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • UCHealth University of Colorado Hospital
      • Boulder, Colorado, Forenede Stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, Forenede Stater, 80210
        • AdventHealth Porter
      • Edwards, Colorado, Forenede Stater, 81632
        • Shaw Cancer Center
      • Greeley, Colorado, Forenede Stater, 80631
        • Banner North Colorado Medical Center
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Longmont, Colorado, Forenede Stater, 80501
        • Longmont United Hospital
      • Loveland, Colorado, Forenede Stater, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, Forenede Stater, 80138
        • AdventHealth Parker
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • University of Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University
      • Waterford, Connecticut, Forenede Stater, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20037
        • George Washington University Medical Center
    • Florida
      • Deerfield Beach, Florida, Forenede Stater, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Cancer Institute
      • Orlando, Florida, Forenede Stater, 32803
        • AdventHealth Orlando
      • Ruskin, Florida, Forenede Stater, 33570
        • Moffitt Cancer Center at SouthShore
      • Tampa, Florida, Forenede Stater, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, Forenede Stater, 33607
        • Moffitt Cancer Center-International Plaza
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Forenede Stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • The Cancer Center of Hawaii-Liliha
    • Idaho
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Effingham, Illinois, Forenede Stater, 62401
        • Crossroads Cancer Center
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Glenview, Illinois, Forenede Stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • O'Fallon, Illinois, Forenede Stater, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn, Illinois, Forenede Stater, 60453-2699
        • Advocate Christ Medical Center
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Rockford, Illinois, Forenede Stater, 61114
        • UW Health Carbone Cancer Center Rockford
      • Springfield, Illinois, Forenede Stater, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • Ascension Saint Vincent Anderson
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Forenede Stater, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Regional Medical Center
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Radiation Oncology Associates PC
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46219
        • IU Health Central Indiana Cancer Centers-East
      • Indianapolis, Indiana, Forenede Stater, 46202
        • IU Health Methodist Hospital
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic - Ames
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Methodist Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Cancer Center
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Olathe, Kansas, Forenede Stater, 66061
        • The University of Kansas Cancer Center - Olathe
      • Overland Park, Kansas, Forenede Stater, 66210
        • University of Kansas Cancer Center-Overland Park
      • Salina, Kansas, Forenede Stater, 67401
        • Salina Regional Health Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Forenede Stater, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, Forenede Stater, 40245
        • UofL Health Medical Center Northeast
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70805
        • LSU Health Baton Rouge-North Clinic
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Our Lady of The Lake
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Our Lady of the Lake Physician Group
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Forenede Stater, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Touro Infirmary
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bel Air, Maryland, Forenede Stater, 21014
        • UM Upper Chesapeake Medical Center
      • Columbia, Maryland, Forenede Stater, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, Forenede Stater, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
      • Silver Spring, Maryland, Forenede Stater, 20910
        • Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, Forenede Stater, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Brighton, Michigan, Forenede Stater, 48114
        • Trinity Health Medical Center - Brighton
      • Brownstown, Michigan, Forenede Stater, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, Forenede Stater, 48126
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, Forenede Stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forenede Stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Novi, Michigan, Forenede Stater, 48377
        • Henry Ford Medical Center-Columbus
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • MyMichigan Medical Center Saginaw
      • Troy, Michigan, Forenede Stater, 48085
        • Corewell Health Beaumont Troy Hospital
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Henry Ford West Bloomfield Hospital
      • Wyandotte, Michigan, Forenede Stater, 48192
        • Henry Ford Wyandotte Hospital
      • Wyoming, Michigan, Forenede Stater, 49519
        • University of Michigan Health - West
    • Minnesota
      • Bemidji, Minnesota, Forenede Stater, 56601
        • Sanford Joe Lueken Cancer Center
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Minnesota Oncology - Burnsville
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, Forenede Stater, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Columbia, Missouri, Forenede Stater, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, Forenede Stater, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64131
        • The University of Kansas Cancer Center-South
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forenede Stater, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68847
        • CHI Health Good Samaritan
      • Omaha, Nebraska, Forenede Stater, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, Forenede Stater, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Hamilton, New Jersey, Forenede Stater, 08690
        • The Cancer Institute of New Jersey Hamilton
      • Livingston, New Jersey, Forenede Stater, 07039
        • Cooperman Barnabas Medical Center
      • Long Branch, New Jersey, Forenede Stater, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, Forenede Stater, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Forenede Stater, 07645
        • Memorial Sloan Kettering Bergen
      • Mount Holly, New Jersey, Forenede Stater, 08060
        • Virtua Memorial
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, Forenede Stater, 07101
        • Rutgers New Jersey Medical School
      • Somerville, New Jersey, Forenede Stater, 08876
        • Robert Wood Johnson University Hospital Somerset
      • Sparta, New Jersey, Forenede Stater, 07871
        • Sparta Cancer Treatment Center
      • Toms River, New Jersey, Forenede Stater, 08755
        • Community Medical Center
      • Voorhees Township, New Jersey, Forenede Stater, 08043
        • Virtua Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • New Mexico Oncology Hematology Consultants
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • University of New Mexico Cancer Center
    • New York
      • Bay Shore, New York, Forenede Stater, 11706
        • South Shore University Hospital
      • Brooklyn, New York, Forenede Stater, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Brooklyn, New York, Forenede Stater, 11220
        • NYU Langone Hospital - Brooklyn
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Canandaigua, New York, Forenede Stater, 14424
        • Sands Cancer Center
      • Commack, New York, Forenede Stater, 11725
        • Memorial Sloan Kettering Commack
      • Elmira, New York, Forenede Stater, 14905
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Harrison, New York, Forenede Stater, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, Forenede Stater, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Forenede Stater, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, Forenede Stater, 10003
        • Mount Sinai Union Square
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • Rochester, New York, Forenede Stater, 14606
        • Wilmot Cancer Institute Radiation Oncology at Greece
      • Sleepy Hollow, New York, Forenede Stater, 10591
        • Memorial Sloan Kettering Sleepy Hollow
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • Uniondale, New York, Forenede Stater, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Albemarle, North Carolina, Forenede Stater, 28002
        • Atrium Health Stanly/LCI-Albemarle
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Atrium Health Pineville/LCI-Pineville
      • Charlotte, North Carolina, Forenede Stater, 28262
        • Atrium Health University City/LCI-University
      • Concord, North Carolina, Forenede Stater, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
      • Kinston, North Carolina, Forenede Stater, 28501
        • ECU Health Oncology Kinston
      • Monroe, North Carolina, Forenede Stater, 28112
        • Atrium Health Union/LCI-Union
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, Forenede Stater, 44304
        • Summa Health System - Akron Campus
      • Avon, Ohio, Forenede Stater, 44011
        • UH Seidman Cancer Center at UH Avon Health Center
      • Barberton, Ohio, Forenede Stater, 44203
        • Summa Health System - Barberton Campus
      • Beachwood, Ohio, Forenede Stater, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Chardon, Ohio, Forenede Stater, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Elyria, Ohio, Forenede Stater, 44035
        • Mercy Cancer Center-Elyria
      • Independence, Ohio, Forenede Stater, 44131
        • Cleveland Clinic Cancer Center Independence
      • Mansfield, Ohio, Forenede Stater, 44903
        • OhioHealth Mansfield Hospital
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Hospital Cancer Center
      • Medina, Ohio, Forenede Stater, 44256
        • Summa Health Medina Medical Center
      • Mentor, Ohio, Forenede Stater, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • UH Seidman Cancer Center at Southwest General Hospital
      • Parma, Ohio, Forenede Stater, 44129
        • University Hospitals Parma Medical Center
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center
      • Ravenna, Ohio, Forenede Stater, 44266
        • University Hospitals Portage Medical Center
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, Forenede Stater, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Strongsville, Ohio, Forenede Stater, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • West Chester, Ohio, Forenede Stater, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westlake, Ohio, Forenede Stater, 44145
        • UHHS-Westlake Medical Center
      • Wooster, Ohio, Forenede Stater, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Saint Luke's Cancer Center - Allentown
      • Altoona, Pennsylvania, Forenede Stater, 16601
        • UPMC Altoona
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • UPMC-Heritage Valley Health System Beaver
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Carlisle, Pennsylvania, Forenede Stater, 17015
        • Carlisle Regional Cancer Center
      • East Stroudsburg, Pennsylvania, Forenede Stater, 18301
        • Pocono Medical Center
      • Easton, Pennsylvania, Forenede Stater, 18045
        • Saint Luke's Hospital-Anderson Campus
      • Erie, Pennsylvania, Forenede Stater, 16505
        • UPMC Hillman Cancer Center Erie
      • Farrell, Pennsylvania, Forenede Stater, 16121
        • UPMC Cancer Center at UPMC Horizon
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Harrisburg, Pennsylvania, Forenede Stater, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Indiana, Pennsylvania, Forenede Stater, 15701
        • IRMC Cancer Center
      • Johnstown, Pennsylvania, Forenede Stater, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • McKeesport, Pennsylvania, Forenede Stater, 15132
        • UPMC Cancer Center at UPMC McKeesport
      • Mechanicsburg, Pennsylvania, Forenede Stater, 17050
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
      • Monroeville, Pennsylvania, Forenede Stater, 15146
        • UPMC Cancer Center - Monroeville
      • Moon Township, Pennsylvania, Forenede Stater, 15108
        • UPMC Hillman Cancer Center in Coraopolis
      • Natrona Heights, Pennsylvania, Forenede Stater, 15065
        • UPMC Cancer Center-Natrona Heights
      • New Castle, Pennsylvania, Forenede Stater, 16105
        • UPMC Jameson
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15215
        • UPMC-Saint Margaret
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • UPMC Jefferson Regional Radiation Oncology
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • UPMC-Passavant Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • UPMC-Saint Clair Hospital Cancer Center
      • Quakertown, Pennsylvania, Forenede Stater, 18951
        • Saint Luke's Hospital - Upper Bucks Campus
      • Seneca, Pennsylvania, Forenede Stater, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Stroudsburg, Pennsylvania, Forenede Stater, 18360
        • Saint Luke's Hospital - Monroe Campus
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • UPMC Uniontown Hospital Radiation Oncology
      • Washington, Pennsylvania, Forenede Stater, 15301
        • UPMC Washington Hospital Radiation Oncology
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, Forenede Stater, 15090
        • Wexford Health and Wellness Pavilion
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Bluffton, South Carolina, Forenede Stater, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, Forenede Stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forenede Stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greer, South Carolina, Forenede Stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, Forenede Stater, 29651
        • Gibbs Cancer Center-Pelham
      • Rock Hill, South Carolina, Forenede Stater, 29730
        • Rock Hill Radiation Therapy Center
      • Seneca, South Carolina, Forenede Stater, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Conroe, Texas, Forenede Stater, 77384
        • UT MD Anderson - The Woodlands
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Galveston, Texas, Forenede Stater, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77079
        • UT MD Anderson - West Houston
      • League City, Texas, Forenede Stater, 77573
        • UTMB Cancer Center at Victory Lakes
      • League City, Texas, Forenede Stater, 77573
        • UT MD Anderson - League City
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Medical Center-Lakeside
      • Sugar Land, Texas, Forenede Stater, 77478
        • UT MD Anderson - Sugar Land
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists-Salt Lake City
      • St. George, Utah, Forenede Stater, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Saint Johnsbury, Vermont, Forenede Stater, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital
      • Hampton, Virginia, Forenede Stater, 23666
        • Sentara Cancer Institute at Sentara CarePlex Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, Forenede Stater, 23298
        • VCU Massey Comprehensive Cancer Center
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Sentara Virginia Beach General Hospital
    • Washington
      • Federal Way, Washington, Forenede Stater, 98003
        • Saint Francis Hospital
      • Kennewick, Washington, Forenede Stater, 99336
        • Tri-Cities Cancer Center
      • Longview, Washington, Forenede Stater, 98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon, Washington, Forenede Stater, 98274
        • Skagit Regional Health Cancer Care Center
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center - Montlake
      • Spokane, Washington, Forenede Stater, 99208
        • Spokane Valley Cancer Center-Mayfair
      • Spokane, Washington, Forenede Stater, 99216
        • Spokane Valley Cancer Center-Mission
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital and Clinics
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Forenede Stater, 26101
        • Camden Clark Medical Center
      • Wheeling, West Virginia, Forenede Stater, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, Forenede Stater, 54409
        • Aspirus Cancer Care-Antigo-Volm Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Johnson Creek, Wisconsin, Forenede Stater, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Forenede Stater, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center
      • Menomonee Falls, Wisconsin, Forenede Stater, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forenede Stater, 54017
        • Cancer Center of Western Wisconsin
      • Oak Creek, Wisconsin, Forenede Stater, 53154
        • Drexel Town Square Health Center
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Aspirus Cancer Care-Wausau
      • West Bend, Wisconsin, Forenede Stater, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
  • Hong Kong
      • Shatin, Hong Kong
        • Chinese University of Hong Kong-Prince of Wales Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • PHASE II INCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)

  • Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx

  • Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible

  • Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)

  • Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:

    • General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;
    • Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation
    • Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave
    • Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement

  • Zubrod performance status of 0-1 within 14 days prior to registration

  • Age >= 18

  • Absolute granulocyte count (AGC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)

  • Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)

  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

  • Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration

  • Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula

  • Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential

  • The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator's discretion

  • Patients with feeding tubes are eligible for the study

  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control

  • Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis

  • PHASE III: Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx

  • PHASE III: Patients with oropharyngeal cancer must have p16-negative based on central review prior to Step 2 registration. All patients with oropharyngeal primary must consent for mandatory tissue submission for central p16 confirmation

  • PHASE III: Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration

    • Note: Patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection. The gross total resection has to be done within 63 days prior to registration. If, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible

  • PHASE III: Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink or tumor in a final separately submitted margin)

  • PHASE III: Pathologic stage III or IV HNSCC (American Joint Committee on Cancer [AJCC] 7th edition), including no distant metastases, based upon the following minimum diagnostic workup:

    • General history and physical examination by a radiation oncologist or medical oncologist within 84 days prior to registration;
    • Examination by an ENT or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror or fiberoptic or direct procedure), if appropriate, is recommended but not required. Intra-operative examination is acceptable documentation.
    • Pre-op Imaging of the head and neck: A neck CT (with contrast and of diagnostic quality) or PET/CT (with contrast and of diagnostic quality) and/or an MRI of the neck of diagnostic quality (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in DICOM format via TRIAD. The report is to be uploaded into Rave.
    • Chest CT scan (with or without contrast) or PET/CT that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: If the PET/CT with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement

  • PHASE III: Zubrod performance status of 0-1 within 14 days prior to registration

  • PHASE III: Age >= 18

  • PHASE III: Leukocytes >= 2,500 cells/mm^3 (obtained within 14 days prior to registration on study)

  • PHASE III: Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)

  • PHASE III: Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)

  • PHASE III: Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable) (obtained within 14 days prior to registration on study)

  • PHASE III: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x institutional ULN may be enrolled) (within 14 days prior to registration)

  • PHASE III: AST or ALT =< 3 x institutional ULN (within 14 days prior to registration)

  • PHASE III: Alkaline phosphatase =< 2.5 x institutional ULN (within 14 days prior to registration)

  • PHASE III: Creatinine clearance (CrCl) >= 50 mL/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula

  • PHASE III: Patients with feeding tubes are eligible for the study

  • PHASE III: Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential

  • PHASE III: All patients must provide study specific informed consent prior to study entry

  • PHASE III: Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:

    • A stable regimen of highly active anti-retroviral therapy (HAART);
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections;
    • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests

Exclusion Criteria:

  • PHASE II EXCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago

  • Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible

  • Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable

  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration

    • Transmural myocardial infarction within 6 months prior to registration

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

      • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration

    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol

      • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients.

  • Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):

  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels

  • Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)

  • Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels

  • Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels

  • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels

  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

  • Prior allergic reaction to cetuximab

  • PHASE III: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) with the following exceptions: T1-2, N0, M0 resected differentiated thyroid carcinoma; Note that noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even if diagnosed and treated < 3 years ago

  • PHASE III: Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible

  • PHASE III: Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy (such as anti-EGF therapy), or immune therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, a prior anti-PD-1, anti-PD-L1, or anti-PD-L2 agent is not permitted

  • PHASE III: Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

  • PHASE III: Severe, active co-morbidity, defined as follows:

    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification; to be eligible for this trial, patients should be class 2B or better within 6 months prior to registration

    • Transmural myocardial infarction within 6 months prior to registration;

    • Severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible.

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;

    • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in a prior radiation field (fibrosis) is permitted, provided that field does not overlap with the planned radiation field for the study cancer;

    • Patients with active tuberculosis (TB) are excluded;

    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease;

      • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
      • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

    • History of allogeneic bone marrow transplantation or solid organ transplantation.

    • A diagnosis of immunodeficiency:

      • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note: HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

    • Is receiving treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to registration.

      • Note: Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
      • Note: The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.

    • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

      • Patients with a history of autoimmune hypothyroidism who are asymptomatic and/or are on a stable dose of thyroid replacement hormone are eligible.
      • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
      • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)

  • PHASE III: Grade 3-4 electrolyte abnormalities (CTCAE, v. 4) within 14 days prior to registration:

    • Serum calcium (ionized or adjusted for albumin) < 7 mg/dL (1.75 mmol/L) or > 12.5 mg/dL (> 3.1 mmol/L) despite intervention to normalize levels;
    • Glucose < 40 mg/dL (< 2.2 mmol/L) or > 250 mg/dL (> 14 mmol/L);
    • Magnesium < 0.9 mg/dL (< 0.4 mmol/L) or > 3 mg/dL (> 1.23 mmol/L) despite intervention to normalize levels;
    • Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels;
    • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels.

  • PHASE III: Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for up to 5 months from last study treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding and unwilling to discontinue are also excluded

  • PHASE III: History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

  • PHASE III: Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other non-oncologic reasons (e.g., osteoporosis) is allowed

  • PHASE III: Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) for non-oncologic reasons who cannot discontinue it before registration

  • PHASE III: Patients with known distant metastatic disease are excluded

  • PHASE III: Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

  • PHASE III: Major surgical procedure within 28 days prior to registration or anticipation of need for a major surgical procedure during the course of the study

  • PHASE III: Administration of a live, attenuated vaccine within 4 weeks prior to registration or anticipation that such a live, attenuated vaccine will be required during the study and for patients receiving atezolizumab, up to 5 months after the last dose of atezolizumab.

    • Influenza vaccination should be given during influenza season only (approximately October to

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Arm 1 (IMRT, cisplatin)

Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Medicin: Cisplatin

Given IV

Andre navne:
  • CDDP
  • Cis-diammindichloridoplatin
  • Cismaplat
  • Cisplatin
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-dichlorplatin
  • Cis-diammindichlor platin (II)
  • Cis-diamindichlorplatin
  • Cis-dichloramin Platin (II)
  • Cis-platinøst diamin dichlorid
  • Cis-platin
  • Cis-platin II
  • Cis-platin II diamin dichlorid
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrones klorid
  • Peyrones salt
  • Placis
  • Plastistil
  • Platamin
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platin
  • Platindiaminodichlorid
  • Platiran
  • Platistin
  • Platosin
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Biopsy Procedure

Undergo biopsy

Andre navne:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Stråling: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andre navne:
  • IMRT
  • Intensitetsmoduleret RT
  • Intensitetsmoduleret strålebehandling
  • Stråling, intensitetsmoduleret strålebehandling
  • Intensitetsmoduleret strålebehandling (procedure)
Andet: Survey Administration

Ancillary studies
Eksperimentel: Arm 2 (IMRT, docetaxel)

Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)
Medicin: Docetaxel

Given IV

Andre navne:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere injektionskoncentrat
  • RP 56976
  • RP-56976
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Stråling: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andre navne:
  • IMRT
  • Intensitetsmoduleret RT
  • Intensitetsmoduleret strålebehandling
  • Stråling, intensitetsmoduleret strålebehandling
  • Intensitetsmoduleret strålebehandling (procedure)
Andet: Survey Administration

Ancillary studies
Eksperimentel: Arm 3 (IMRT, docetaxel, cetuximab)

Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Medicin: Docetaxel

Given IV

Andre navne:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere injektionskoncentrat
  • RP 56976
  • RP-56976
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Biopsy Procedure

Undergo biopsy

Andre navne:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Stråling: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andre navne:
  • IMRT
  • Intensitetsmoduleret RT
  • Intensitetsmoduleret strålebehandling
  • Stråling, intensitetsmoduleret strålebehandling
  • Intensitetsmoduleret strålebehandling (procedure)
Biologisk: Cetuximab

Given IV

Andre navne:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Kimærisk anti-EGFR monoklonalt antistof
  • Kimærisk MoAb C225
  • Kimært monoklonalt antistof C225
  • C-225
  • C 225
  • Cetuximab-cetu
  • Cetuxa
  • ENZ 124
  • ENZ-124
  • ENZ124
Andet: Survey Administration

Ancillary studies
Eksperimentel: Arm 4 (IMRT, cisplatin, atezolizumab)

Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Medicin: Cisplatin

Given IV

Andre navne:
  • CDDP
  • Cis-diammindichloridoplatin
  • Cismaplat
  • Cisplatin
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-dichlorplatin
  • Cis-diammindichlor platin (II)
  • Cis-diamindichlorplatin
  • Cis-dichloramin Platin (II)
  • Cis-platinøst diamin dichlorid
  • Cis-platin
  • Cis-platin II
  • Cis-platin II diamin dichlorid
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrones klorid
  • Peyrones salt
  • Placis
  • Plastistil
  • Platamin
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platin
  • Platindiaminodichlorid
  • Platiran
  • Platistin
  • Platosin
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Biopsy Procedure

Undergo biopsy

Andre navne:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Atezolizumab

Given IV

Andre navne:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO 5541267
  • RO-5541267
Stråling: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andre navne:
  • IMRT
  • Intensitetsmoduleret RT
  • Intensitetsmoduleret strålebehandling
  • Stråling, intensitetsmoduleret strålebehandling
  • Intensitetsmoduleret strålebehandling (procedure)
Andet: Survey Administration

Ancillary studies

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-free survival (Phase II)
Tidsramme: From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years

Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.
From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years
Overall survival (Phase III)
Tidsramme: From date of randomization to death due to any cause, assessed up to 7 years

Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test. Multivariate analysis will be performed using the Cox proportional hazards model.
From date of randomization to death due to any cause, assessed up to 7 years

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Local-regional failure
Tidsramme: From date of randomization until date of local-regional recurrence, assessed up to 7 years

The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
From date of randomization until date of local-regional recurrence, assessed up to 7 years
Distant metastasis
Tidsramme: From date of randomization to date of distant metastasis, assessed up to 7 years

The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.
From date of randomization to date of distant metastasis, assessed up to 7 years
Toxicity
Tidsramme: From start of treatment to death or last follow-up

Adverse events will be graded using Common Terminology Criteria for Adverse Events version 4.0. Rates of grade 3+ adverse events overall will be compared between arms by Chi-square test, or Fisher's exact test.
From start of treatment to death or last follow-up
Patient-reported outcome, symptom burden
Tidsramme: Time from randomization to a first recovery within at least one MID unit of total symptom severity compared to the baseline (reference) score

Time to recovery of baseline total symptom severity from the MD Anderson Symptom Inventory - Head and Neck. The cumulative incidence method will be used to estimate the event rates, and the event rates between arms will be compared using a cause-specific log rank test. The Fine-Gray subdistribution hazards model may be applied to further explore outcomes by treatment arm and other covariates.
Time from randomization to a first recovery within at least one MID unit of total symptom severity compared to the baseline (reference) score
Quality of life
Tidsramme: Baseline and 1 year post radiation therapy

Quality of life change from baseline at 1-year post RT, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT) Trial Outcome Index (TOI). FACT TOI is a validated efficient summary index of physical/functional outcomes, and disease site-specific items, which is highly reliable and sensitive to change in performance status rating. A constrained longitudinal data analysis model will be fitted with all the time points (discrete), the treatment factor and its interaction. The secondary non-inferiority patient-reported outcome hypothesis will be tested using a confidence interval approach.
Baseline and 1 year post radiation therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National Cancer Institute (NCI)

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Paul M Harari, NRG Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
22. marts 2013

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. januar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
12. marts 2013

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
12. marts 2013

Først opslået (Anslået)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
14. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
11. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NCI-2013-00500
  • U10CA180868 (U.S. NIH-bevilling/kontrakt)
  • U10CA021661 (U.S. NIH-bevilling/kontrakt)
  • NCI-2013-00500 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RTOG-1216 (Anden identifikator: CTEP)
  • RTOG-1216 (Anden identifikator: NRG Oncology)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger