Strahlentherapie bei der Behandlung von Patienten mit Metastasen zu den Lymphknoten im Nacken von einem unbekannten Primärtumor

Randomisierte Phase-III-Studie zur Auswahl des Zielvolumens in der postoperativen Strahlentherapie für zervikale Lymphknotenmetastasen von Plattenepithelkarzinomen aus und unbekanntem Primär (CUP)

Sponsoren

Hauptsponsor: European Organisation for Research and Treatment of Cancer - EORTC

Mitarbeiter: Radiation Therapy Oncology Group
NCIC Clinical Trials Group
Danish Head and Neck Cancer Group

Quelle European Organisation for Research and Treatment of Cancer - EORTC
Kurze Zusammenfassung

RATIONALE: Die Strahlentherapie verwendet energiereiche Röntgenstrahlen, um Tumorzellen zu schädigen. Strahlung geben Eine Therapie auf unterschiedliche Weise kann mehr Tumorzellen abtöten. Es ist noch nicht bekannt, welches Regime von Strahlentherapie ist wirksamer bei der Behandlung von Patienten mit Metastasen in der Lymphe Knoten im Nacken.

ZWECK: Randomisierte Phase-III-Studie zum Vergleich verschiedener Strahlentherapien in Behandlung von Patienten mit Metastasen zu den Lymphknoten im Nacken von einem unbekannten primären Tumor.

detaillierte Beschreibung

ZIELE:

- Vergleichen Sie das krankheitsfreie Überleben von Patienten mit zervikalen Lymphknotenmetastasen von Plattenepithelkarzinom eines unbekannten primären mit selektiver Bestrahlung behandelten vs. umfangreiche Bestrahlung.

- Vergleichen Sie das Gesamtüberleben von Patienten, die mit diesen Therapien behandelt wurden.

- Vergleichen Sie die Inzidenz von akuten und späten Nebenwirkungen im Kopf- und Halsbereich in Patienten, die mit diesen Regimen behandelt wurden.

- Vergleichen Sie die Kontrolle des Halses und die Inzidenz der nachfolgenden primären in Kopf und Hals Region bei Patienten, die mit diesen Regimen behandelt wurden.

- Vergleichen Sie die Lebensqualität von Patienten, die mit diesen Therapien behandelt wurden.

ÜBERBLICK: Dies ist eine randomisierte, offene, multizentrische Studie. Die Patienten sind geschichtet je nach Krankheitsstadium (N1-2a vs N2b-3), Strahlentechnik (2D vs 3D konform vs. intensitätsmoduliert) und teilnehmendes Zentrum. Die Patienten werden zu 1 von 2 Behandlungen randomisiert Waffen.

- Arm I: Die Patienten werden einmal selektiv auf das ipsilaterale Niveau des Halses bestrahlt täglich 5 Tage die Woche für 6 Wochen.

- Arm II: Patienten werden einer umfassenden Bestrahlung des Halses unterzogen (Nasopharynx, oropharyngeale, hypopharyngeale und laryngeale Schleimhaut und ipsilaterale Halsknotenbereiche auf beide Seiten des Halses) einmal täglich 5 Tage die Woche für 6 Wochen.

In beiden Armen wird die Behandlung fortgesetzt, wenn keine inakzeptable Toxizität oder Krankheit vorliegt Fortschreiten.

Die Lebensqualität wird zu Studienbeginn, in Woche 4, am letzten Tag der Therapie und dann beurteilt alle 3 Monate für 1 Jahr.

Die Patienten werden am 30. Tag alle 3 Monate für 3 Jahre, alle 6 Monate für 2 Jahre und beobachtet dann jährlich danach.

PROJEKTIERTES ACCRUAL: Insgesamt werden 600 Patienten (300 pro Behandlungsarm) dafür akkumuliert innerhalb von 7 Jahren studieren.

Gesamtstatus Abgeschlossen
Anfangsdatum Juli 2002
Primäres Abschlussdatum Juli 2004
Phase Phase 3
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
Krankheitsfreies Überleben
Einschreibung 600
Bedingung
Intervention

Interventionsart: Strahlung

Interventionsname: Strahlentherapie

Teilnahmeberechtigung

Kriterien:

KRANKHEITSEIGENSCHAFTEN:

- Histologisch bestätigtes Plattenepithelkarzinom bei zervikaler Lymphknotenmetastasierung von einem unbekannten Primärtumor

- Histopathologischer Grad WHO 1-3

- Pathologisches Stadium N1, N2a, N2b oder N3

- Kein N2c (d. H. Bilaterale metastatische Knoten)

- Kein einzelner Knoten in der Fossa supraclavicularis oder im submandibulären Bereich

- Keine Hinweise auf Primärtumor in Kopf und Hals, Lunge, Speiseröhre oder anderen Stellen

- Vorherige radikalische, radikalisch modifizierte oder erweiterte radikalische Dissektion innerhalb der letzten 8 Wochen

- Selektive Nackendissektion erlaubt (Chirurg muss begründen, warum Standardverfahren wurde nicht durchgeführt)

- Keine Knotenentfernung allein

- R0- oder R1-Krankheit nach Dissektion

- Keine Fernmetastasen

PATIENTENEIGENSCHAFTEN:

Alter

- 18 und älter

Performanz Status

- ECOG 0-2 ODER

- Karnofsky 60-100%

Lebenserwartung

- Unbestimmt

Hämatopoetisch

- Unbestimmt

Hepatisch

- Unbestimmt

Nieren

- Unbestimmt

Andere

- Fähigkeit und Bereitschaft, Fragebögen zur Lebensqualität auszufüllen

- Keine andere frühere oder gleichzeitige Malignität außer ausreichend behandelter Basalzellhaut Krebs oder Karzinom in situ des Gebärmutterhalses

- Kein psychologischer, familiärer, soziologischer oder geografischer Zustand, der dies tun würde Studienkonformität ausschließen

- Nicht schwanger oder stillend

- Fruchtbare Patienten müssen eine wirksame Verhütungsmethode anwenden

VORHERIGE KONKURRENTTHERAPIE:

Biologische Therapie

- Unbestimmt

Chemotherapie

- Gleichzeitige Chemotherapie erlaubt

Endokrine Therapie

- Unbestimmt

Strahlentherapie

- Unbestimmt

Operation

- Siehe Krankheitsmerkmale

Andere

- Keine andere vorherige Therapie für Karzinome unbekannter primärer als Halssektion

Geschlecht: Weiblich

Mindestalter: 18 Jahre

Maximales Alter: 120 Jahre

Gesunde Freiwillige: Nein

Insgesamt offiziell
Ort
Einrichtung:
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama, 35294-3300, United States
Comprehensive Cancer Institute | Huntsville, Alabama, 35801, United States
MBCCOP - Gulf Coast | Mobile, Alabama, 36607, United States
Montgomery Cancer Center | Montgomery, Alabama, 36106-3657, United States
DCH Cancer Treatment Center | Tuscaloosa, Alabama, 35401, United States
Foundation for Cancer Research and Education | Phoenix, Arizona, 85013, United States
Providence Saint Joseph Medical Center - Burbank | Burbank, California, 91505, United States
Mount Diablo Medical Center | Concord, California, 94524-4110, United States
City of Hope Comprehensive Cancer Center | Duarte, California, 91010-3000, United States
California Cancer Center | Fresno, California, 93720, United States
Saint Agnes Cancer Center | Fresno, California, 93720, United States
Sutter Health Western Division Cancer Research Group | Greenbrae, California, 94904, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California, 92354, United States
Veterans Affairs Medical Center - Long Beach | Long Beach, California, 90822, United States
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California, 90095-1714, United States
CCOP - Bay Area Tumor Institute | Oakland, California, 94609-3305, United States
Huntington Cancer Center at Huntington Hospital | Pasadena, California, 91105, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California, 91767, United States
Radiation Oncology Centers - Sacramento | Sacramento, California, 95816, United States
Radiation Medical Group, Incorporated | San Diego, California, 92101, United States
Naval Medical Center - San Diego | San Diego, California, 92134-3202, United States
UCSF Comprehensive Cancer Center | San Francisco, California, 94115, United States
O'Connor Hospital | San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California, 95403, United States
St. Joseph's Regional Cancer Center | Stockton, California, 95204, United States
Torrance Memorial Medical Center | Torrance, California, 90505, United States
David Grant Medical Center | Travis Air Force Base, California, 94535, United States
Memorial Hospital Cancer Center | Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado, 80010, United States
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado, 80224, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado, 81502-1628, United States
Hospital of St. Raphael | New Haven, Connecticut, 06511, United States
Yale Comprehensive Cancer Center | New Haven, Connecticut, 06520-8040, United States
CCOP - Christiana Care Health Services | Newark, Delaware, 19713, United States
Sibley Memorial Hospital | Washington, District of Columbia, 20016, United States
21st Century Oncology - Fort Myers | Fort Myers, Florida, 33901-8082, United States
Shands Cancer Center at the University of Florida Health Science Center | Gainesville, Florida, 32610-0385, United States
Florida Radiation Oncology Group | Jacksonville, Florida, 32207, United States
Holmes Regional Medical Center | Melbourne, Florida, 32901-3276, United States
CCOP - Mount Sinai Medical Center | Miami Beach, Florida, 33140, United States
University of Miami Sylvester Cancer Center | Miami, Florida, 33136, United States
Baptist Hospital of Miami | Miami, Florida, 33176-2197, United States
MD Anderson Cancer Center Orlando | Orlando, Florida, 32806-2134, United States
Bay Medical Center | Panama City, Florida, 32401, United States
Gulf Coast Cancer Treatment Center | Panama City, Florida, 32405-4587, United States
Sarasota Radiation and Medical Oncology Center | Sarasota, Florida, 34233, United States
Tallahassee Memorial Hospital | Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida, 33612-9497, United States
Winship Cancer Institute of Emory University | Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional | Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia, 31901, United States
Regional Radiation Oncology Center at Rome | Rome, Georgia, 30165, United States
MBCCOP - Hawaii | Honolulu, Hawaii, 96813, United States
Northwest Community Hospital | Arlington Heights, Illinois, 60005, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois, 60611-3013, United States
CCOP - Central Illinois | Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital | Harvey, Illinois, 60426, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center | Park Ridge, Illinois, 60068, United States
CCOP - Scott and White Hospital | Peoria, Illinois, 61602, United States
Methodist Medical Center of Illinois | Peoria, Illinois, 61636, United States
St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana, 46016, United States
Bloomington Hospital | Bloomington, Indiana, 47402, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana, 46202, United States
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana, 46206-1367, United States
Community Regional Cancer Care | Indianapolis, Indiana, 46219, United States
Oncology Institute of Greater Lafayette | Lafayette, Indiana, 47904, United States
Ball Memorial Hospital Cancer Center | Muncie, Indiana, 47303-3499, United States
CCOP - Northern Indiana CR Consortium | South Bend, Indiana, 46601, United States
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa, 52001, United States
St. Elizabeth Medical Center | Edgewood, Kentucky, 41017, United States
Central Baptist Hospital | Lexington, Kentucky, 40503, United States
Cancer Center at Lexington Clinic | Lexington, Kentucky, 40504, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky, 40536-0293, United States
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology Center at Caritas Regional Cancer Center | Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville, Kentucky, 42431, United States
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana, 70809, United States
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana, 70112-2699, United States
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana, 70112, United States
CCOP - Ochsner | New Orleans, Louisiana, 70121, United States
Maine Medical Center | Portland, Maine, 04102, United States
Anne Arundel Oncology Center | Annapolis, Maryland, 21401, United States
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland, 21204, United States
Harbor Hospital Center | Baltimore, Maryland, 21215-1290, United States
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States
St. Agnes Cancer Center | Baltimore, Maryland, 21229, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland, 21231-2410, United States
Peninsula Regional Medical Center | Salisbury, Maryland, 21801, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts, 02114, United States
Cancer Research Center at Boston Medical Center | Boston, Massachusetts, 02118, United States
Cape Cod Hospital | Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts, 02130, United States
NSMC Cancer Center | Peabody, Massachusetts, 01960, United States
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109-0010, United States
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan, 48202, United States
McLaren Regional Cancer Center | Flint, Michigan, 48532-3685, United States
CCOP - Kalamazoo | Kalamazoo, Michigan, 49007-3731, United States
Marquette General Hospital | Marquette, Michigan, 49855, United States
MidMichigan Medical Center - Midland | Midland, Michigan, 48670, United States
CCOP - Beaumont | Royal Oak, Michigan, 48073-6769, United States
William Beaumont Hospital - Royal Oak | Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy | Troy, Michigan, 48085, United States
Fairview University Medical Center - University Campus | Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center | Rochester, Minnesota, 55905-0001, United States
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, 55416, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri, 65203, United States
CCOP - Kansas City | Kansas City, Missouri, 64131, United States
St. Louis University Hospital Cancer Center | Saint Louis, Missouri, 63110-0250, United States
Siteman Cancer Center | Saint Louis, Missouri, 63110, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium | Billings, Montana, 59101, United States
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska, 68106, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska, 68114-4199, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska, 68198-7521, United States
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada, 89106, United States
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, 89109, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756-0002, United States
Elliot Regional Cancer Center | Manchester, New Hampshire, 03103, United States
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey, 07019, United States
John F. Kennedy Medical Center | Edison, New Jersey, 08818, United States
Monmouth Medical Center | Long Branch, New Jersey, 07740-6395, United States
South Jersey Regional Cancer Center | Millville, New Jersey, 08332, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey | New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center | Newark, New Jersey, 07112, United States
Atlantic City Medical Center | Pomona, New Jersey, 08240, United States
Medical Center of Princeton | Princeton, New Jersey, 08540, United States
Valley Hospital | Ridgewood, New Jersey, 07450, United States
Community Medical Center | Toms River, New Jersey, 08755, United States
Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey, 08629, United States
Associated Radiologists, P.A. | Warren, New Jersey, 07059, United States
Radiation Oncology Associates of Albuquerque | Albuquerque, New Mexico, 87109, United States
Lourdes Regional Cancer Center | Binghamton, New York, 13905, United States
SUNY Downstate Medical Center | Brooklyn, New York, 11203, United States
New York Methodist Hospital | Brooklyn, New York, 11215, United States
Finger Lakes Radiation Oncology Center | Clifton Springs, New York, 14432, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | East Syracuse, New York, 13057, United States
CCOP - North Shore University Hospital | Manhasset, New York, 11030, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York, 10003, United States
Memorial Sloan-Kettering Cancer Center | New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York, 10032, United States
Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York, 12901-1490, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York, 14642, United States
North Shore Radiation Oncology | Setauket, New York, 11733, United States
University Hospital at State University of New York - Upstate Medical University | Syracuse, New York, 13210, United States
Riverhill Radiation Oncology | Yonkers, New York, 10701, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina, 27599-7295, United States
Batte Cancer Center at Northeast Medical Center | Concord, North Carolina, 28025, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville, North Carolina, 27835-6028, United States
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina, 27157-1082, United States
Trinity Cancer Care Center | Minot, North Dakota, 58701, United States
Akron General Medical Center | Akron, Ohio, 44302, United States
Akron City Hospital | Akron, Ohio, 44304, United States
Cancer Center at Christ Hospital | Cincinnati, Ohio, 45219, United States
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio, 45219, United States
Ireland Cancer Center | Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland | Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
CCOP - Columbus | Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio, 43210-1240, United States
CCOP - Dayton | Dayton, Ohio, 45429, United States
Parma Community General Hospital | Parma, Ohio, 44129, United States
CCOP - Toledo Community Hospital | Toledo, Ohio, 43623-3456, United States
Frank C. Love Cancer Institute at St. Anthony Hospital | Oklahoma City, Oklahoma, 73102, United States
Oklahoma University Medical Center | Oklahoma City, Oklahoma, 73104, United States
St. John Health System | Tulsa, Oklahoma, 74104, United States
CCOP - Oklahoma | Tulsa, Oklahoma, 74136, United States
CCOP - Columbia River Oncology Program | Portland, Oregon, 97225, United States
Abington Memorial Hospital | Abington, Pennsylvania, 19001, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania, 18105, United States
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center | Danville, Pennsylvania, 17822-2001, United States
Mercy Fitzgerald Hospital | Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania, 19026, United States
Dale and Frances Hughes Cancer Center | East Stroudsburg, Pennsylvania, 18301, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033-0850, United States
Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania, 19104-4283, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Cancer Center | Philadelphia, Pennsylvania, 19141-3098, United States
Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212, United States
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania, 15224, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, 15236, United States
Reading Hospital and Medical Center | Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania, 18501, United States
Wilkes-Barre General Hospital | Wilkes-Barre, Pennsylvania, 18764-0001, United States
CCOP - MainLine Health | Wynnewood, Pennsylvania, 19096, United States
Wellspan Health - York Cancer Center | York, Pennsylvania, 17403, United States
Roger Williams Medical Center | Providence, Rhode Island, 02908-4735, United States
CCOP - Greenville | Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina | Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital | Rapid City, South Dakota, 57709, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson, Tennessee, 38301, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee, 37232-5671, United States
Harrington Cancer Center | Amarillo, Texas, 79106, United States
Arlington Cancer Center | Arlington, Texas, 76012, United States
University of Texas Medical Branch | Galveston, Texas, 77555-0209, United States
University of Texas - MD Anderson Cancer Center | Houston, Texas, 77030-4009, United States
Wilford Hall Medical Center | Lackland Air Force Base, Texas, 78236-5300, United States
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas, 79410-1894, United States
University of Texas Health Science Center at San Antonio | San Antonio, Texas, 78284-7811, United States
Utah Valley Regional Medical Center - Provo | Provo, Utah, 84604, United States
Dixie Regional Medical Center | Saint George, Utah, 84770, United States
University of Utah Health Sciences Center | Salt Lake City, Utah, 84132, United States
LDS Hospital | Salt Lake City, Utah, 84143, United States
Green Mountain Oncology Group | Bennington, Vermont, 05201, United States
Vermont Cancer Center at University of Vermont | Burlington, Vermont, 05405-0075, United States
Cancer Center at the University of Virginia | Charlottesville, Virginia, 22908, United States
RMH Regional Cancer Center | Harrisonburg, Virginia, 22801, United States
Naval Medical Center, Portsmouth | Portsmouth, Virginia, 23708-2197, United States
Bon Secours - St. Mary's Hospital | Richmond, Virginia, 23226, United States
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia, 23298-0058, United States
Cancer Institute at Virginia Mason Medical Center | Seattle, Washington, 98111, United States
University Cancer Center at University of Washington Medical Center | Seattle, Washington, 98195-6043, United States
Deaconess Medical Center | Spokane, Washington, 99204, United States
Yakima Valley Memorial Hospital | Yakima, Washington, 98902, United States
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia, 26003, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin, 54301, United States
St. Vincent Hospital | Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center | Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin, 53792, United States
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin, 54449, United States
Marshfield Clinic | Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital | Menomonee Falls, Wisconsin, 53051, United States
Columbia Hospital | Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center | Milwaukee, Wisconsin, 53215, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin, 53295, United States
All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin, 53188, United States
Cliniques Universitaires Saint-Luc | Brussels, 1200, Belgium
Clinique Sainte Elisabeth | Namur, 5000, Belgium
Tom Baker Cancer Center - Calgary | Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada
Doctor Leon Richard Oncology Centre | Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital | Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation | St. Johns, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre | Halifax, Nova Scotia, B3H 1V7, Canada
Margaret and Charles Juravinski Cancer Centre | Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre | Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre | London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre | Ottawa, Ontario, K1H 1C4, Canada
Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital | Sudbury, Ontario, P3E 5J1, Canada
Northwestern Ontario Regional Cancer Care | Thunder Bay, Ontario, P7B 6V4, Canada
Toronto Sunnybrook Regional Cancer Centre | Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital | Toronto, Ontario, M5G 2M9, Canada
CHUS-Hopital Fleurimont | Fleurimont, Quebec, J1H 5N4, Canada
Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, H2L 4MI, Canada
McGill University | Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec | Quebec City, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre | Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre | Saskatoon, Saskatchewan, S7N 4H4, Canada
Aarhus University Hospital - Aarhus Sygehus | Aarhus, DK-8000, Denmark
Vrije Universiteit Medisch Centrum | Amsterdam, 1007 MB, Netherlands
Centre Hospitalier Universitaire Vaudois | Lausanne, CH-1011, Switzerland
Standort Länder

Belgium

Kanada

Dänemark

Niederlande

Schweiz

Vereinigte Staaten

Überprüfungsdatum

Juli 2018

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert Nein
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Selective irradiation

Art: Experimental

Beschreibung: Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).

Etikette: Umfangreiche Strahlung + ipsilaterale Ebenen

Art: Aktiver Komparator

Beschreibung: Bestrahlung der gesamten Schleimhaut von Kehlkopf, Hypopharynx, Oropharynx und Nasopharynx sowie auf beiden Seiten des Halses (Level I-V) bis zu einer prophylaktischen Dosis von 50 Gy (25 x 2 Gy in 5 Wochen). Bestrahlung des ipsilateralen Stufe I - V des Halses sollte mit einem zusätzlichen 10-Gy-Boost für eine Gesamtdosis von 60 Gy (30 x 2 Gy in 6 Wochen) fortgesetzt werden.

Studiendesign Info

Zuweisung: Zufällig

Interventionsmodell: Parallele Zuordnung

Hauptzweck: Behandlung

Maskierung: Keine (Open Label)

Quelle: ClinicalTrials.gov