Carcinoma of Unknown Primary Clinical Trial
Official title:
Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary (CUP)
NCT number | NCT00047125 |
Other study ID # | EORTC-24001-22005 |
Secondary ID | EORTC-24001EORTC |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2002 |
Verified date | July 2018 |
Source | European Organisation for Research and Treatment of Cancer - EORTC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
therapy in different ways may kill more tumor cells. It is not yet known which regimen of
radiation therapy is more effective in treating patients who have metastases to the lymph
nodes in the neck.
PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in
treating patients who have metastases to the lymph nodes in the neck from an unknown primary
tumor.
Status | Completed |
Enrollment | 600 |
Est. completion date | |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor - Histopathological grade WHO 1-3 - Pathological stage N1, N2a, N2b, or N3 - No N2c (i.e., bilateral metastatic nodes) - No single node in supraclavicular fossa or submandibular area - No evidence of primary tumor in head and neck, lung, esophageal, or other site - Prior radical, radical modified, or extended radical dissection within the past 8 weeks - Selective neck dissection allowed (surgeon must justify why standard procedure was not performed) - No node excision alone - R0 or R1 disease after dissection - No distant metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Able and willing to complete quality of life questionnaires - No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical condition that would preclude study compliance - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Concurrent chemotherapy allowed Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No other prior therapy for carcinoma of unknown primary except neck dissection |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Clinique Sainte Elisabeth | Namur | |
Canada | Tom Baker Cancer Center - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | CHUS-Hopital Fleurimont | Fleurimont | Quebec |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario |
Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | McGill University | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador |
Canada | Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital | Sudbury | Ontario |
Canada | Northwestern Ontario Regional Cancer Care | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Denmark | Aarhus University Hospital - Aarhus Sygehus | Aarhus | |
Netherlands | Vrije Universiteit Medisch Centrum | Amsterdam | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Akron City Hospital | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | Radiation Oncology Associates of Albuquerque | Albuquerque | New Mexico |
United States | John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | St. John's Cancer Center at St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Anne Arundel Oncology Center | Annapolis | Maryland |
United States | Arlington Cancer Center | Arlington | Texas |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Harbor Hospital Center | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | St. Agnes Cancer Center | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Green Mountain Oncology Group | Bennington | Vermont |
United States | St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Lourdes Regional Cancer Center | Binghamton | New York |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Bloomington Hospital | Bloomington | Indiana |
United States | Cancer Research Center at Boston Medical Center | Boston | Massachusetts |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Vermont Cancer Center at University of Vermont | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Cancer Center at the University of Virginia | Charlottesville | Virginia |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Cancer Center at Christ Hospital | Cincinnati | Ohio |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Finger Lakes Radiation Oncology Center | Clifton Springs | New York |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Batte Cancer Center at Northeast Medical Center | Concord | North Carolina |
United States | Mount Diablo Medical Center | Concord | California |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Mercy Fitzgerald Hospital | Darby | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Dale and Frances Hughes Cancer Center | East Stroudsburg | Pennsylvania |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | East Syracuse | New York |
United States | St. Elizabeth Medical Center | Edgewood | Kentucky |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | McLaren Regional Cancer Center | Flint | Michigan |
United States | 21st Century Oncology - Fort Myers | Fort Myers | Florida |
United States | California Cancer Center | Fresno | California |
United States | Saint Agnes Cancer Center | Fresno | California |
United States | Shands Cancer Center at the University of Florida Health Science Center | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health Western Division Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville | North Carolina |
United States | RMH Regional Cancer Center | Harrisonburg | Virginia |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Comprehensive Cancer Institute | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Community Regional Cancer Care | Indianapolis | Indiana |
United States | Methodist Cancer Center at Methodist Hospital | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Florida Radiation Oncology Group | Jacksonville | Florida |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | Oncology Institute of Greater Lafayette | Lafayette | Indiana |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Cancer Center at Lexington Clinic | Lexington | Kentucky |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | Louisville Radiation Oncology Center at Caritas Regional Cancer Center | Louisville | Kentucky |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville | Kentucky |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Marquette General Hospital | Marquette | Michigan |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Holmes Regional Medical Center | Melbourne | Florida |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | University of Miami Sylvester Cancer Center | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MidMichigan Medical Center - Midland | Midland | Michigan |
United States | South Jersey Regional Cancer Center | Millville | New Jersey |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Fairview University Medical Center - University Campus | Minneapolis | Minnesota |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | Montgomery Cancer Center | Montgomery | Alabama |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey |
United States | Ball Memorial Hospital Cancer Center | Muncie | Indiana |
United States | Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Hospital of St. Raphael | New Haven | Connecticut |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana |
United States | Beth Israel Medical Center - Philipps Ambulatory Care Center | New York | New York |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Frank C. Love Cancer Institute at St. Anthony Hospital | Oklahoma City | Oklahoma |
United States | Oklahoma University Medical Center | Oklahoma City | Oklahoma |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | MD Anderson Cancer Center Orlando | Orlando | Florida |
United States | Bay Medical Center | Panama City | Florida |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Parma Community General Hospital | Parma | Ohio |
United States | Huntington Cancer Center at Huntington Hospital | Pasadena | California |
United States | NSMC Cancer Center | Peabody | Massachusetts |
United States | CCOP - Scott and White Hospital | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Atlantic City Medical Center | Pomona | New Jersey |
United States | Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Maine Medical Center | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Medical Center of Princeton | Princeton | New Jersey |
United States | Roger Williams Medical Center | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Bon Secours - St. Mary's Hospital | Richmond | Virginia |
United States | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Regional Radiation Oncology Center at Rome | Rome | Georgia |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | William Beaumont Hospital - Royal Oak | Royal Oak | Michigan |
United States | Radiation Oncology Centers - Sacramento | Sacramento | California |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Siteman Cancer Center | Saint Louis | Missouri |
United States | St. Louis University Hospital Cancer Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | Radiation Medical Group, Incorporated | San Diego | California |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | O'Connor Hospital | San Jose | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | Cancer Institute at Virginia Mason Medical Center | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | North Shore Radiation Oncology | Setauket | New York |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Deaconess Medical Center | Spokane | Washington |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | St. Joseph's Regional Cancer Center | Stockton | California |
United States | University Hospital at State University of New York - Upstate Medical University | Syracuse | New York |
United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | Torrance Memorial Medical Center | Torrance | California |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Fox Chase Cancer Center at St. Francis Medical Center | Trenton | New Jersey |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | CCOP - Oklahoma | Tulsa | Oklahoma |
United States | St. John Health System | Tulsa | Oklahoma |
United States | DCH Cancer Treatment Center | Tuscaloosa | Alabama |
United States | Associated Radiologists, P.A. | Warren | New Jersey |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia |
United States | Wilkes-Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Riverhill Radiation Oncology | Yonkers | New York |
United States | Wellspan Health - York Cancer Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | Danish Head and Neck Cancer Group, NCIC Clinical Trials Group, Radiation Therapy Oncology Group |
United States, Belgium, Canada, Denmark, Netherlands, Switzerland,
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