Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
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Trial Identification
Brief Title: Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
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)
Study ID: NCT00047125
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation. * Compare the overall survival of patients treated with these regimens. * Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens. * Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens. * Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (N1-2a vs N2b-3), radiation technique (2D vs 3D conformal vs intensity-modulated), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks. * Arm II: Patients undergo extensive irradiation of the neck (nasopharyngeal, oropharyngeal, hypopharyngeal, and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck) once daily 5 days a week for 6 weeks. In both arms, treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, at week 4, on the last day of therapy, and then every 3 months for 1 year. Patients are followed at day 30, every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 7 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Comprehensive Cancer Institute, Huntsville, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
Montgomery Cancer Center, Montgomery, Alabama, United States
DCH Cancer Treatment Center, Tuscaloosa, Alabama, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Mount Diablo Medical Center, Concord, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
California Cancer Center, Fresno, California, United States
Saint Agnes Cancer Center, Fresno, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, 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
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Huntington Cancer Center at Huntington Hospital, Pasadena, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona, California, United States
Radiation Oncology Centers - Sacramento, Sacramento, California, United States
Radiation Medical Group, Incorporated, San Diego, California, United States
Naval Medical Center - San Diego, 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
St. Joseph's Regional Cancer Center, Stockton, California, United States
Torrance Memorial Medical Center, Torrance, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
Memorial Hospital Cancer Center, Colorado Springs, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
Hospital of St. Raphael, New Haven, Connecticut, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
21st Century Oncology - Fort Myers, Fort Myers, Florida, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
Florida Radiation Oncology Group, Jacksonville, Florida, United States
Holmes Regional Medical Center, Melbourne, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Miami Sylvester Cancer Center, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, 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
Sarasota Radiation and Medical Oncology Center, Sarasota, Florida, United States
Tallahassee Memorial Hospital, Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center, Columbus, Georgia, United States
Regional Radiation Oncology Center at Rome, Rome, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
CCOP - Scott and White Hospital, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
St. John's Cancer Center at St. John's Medical Center, Anderson, Indiana, United States
Bloomington Hospital, Bloomington, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States
Community Regional Cancer Care, Indianapolis, Indiana, United States
Oncology Institute of Greater Lafayette, Lafayette, Indiana, United States
Ball Memorial Hospital Cancer Center, Muncie, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital, Dubuque, Iowa, United States
St. Elizabeth Medical Center, Edgewood, Kentucky, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Cancer Center at Lexington Clinic, Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 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
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County, Madisonville, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Maine Medical Center, Portland, Maine, United States
Anne Arundel Oncology Center, Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
Harbor Hospital Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
St. Agnes Cancer Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Peninsula Regional Medical Center, Salisbury, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Cape Cod Hospital, Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States
NSMC Cancer Center, Peabody, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
McLaren Regional Cancer Center, Flint, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Marquette General Hospital, Marquette, Michigan, United States
MidMichigan Medical Center - Midland, Midland, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Hospital Cancer Center, Saint Louis, Missouri, United States
Siteman Cancer Center, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, 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
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
Elliot Regional Cancer Center, Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
John F. Kennedy Medical Center, Edison, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
South Jersey Regional Cancer Center, Millville, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Atlantic City Medical Center, Pomona, New Jersey, United States
Medical Center of Princeton, Princeton, New Jersey, United States
Valley Hospital, Ridgewood, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center, Trenton, New Jersey, United States
Associated Radiologists, P.A., Warren, New Jersey, United States
Radiation Oncology Associates of Albuquerque, Albuquerque, New Mexico, United States
Lourdes Regional Cancer Center, Binghamton, New York, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
New York Methodist Hospital, Brooklyn, New York, United States
Finger Lakes Radiation Oncology Center, Clifton Springs, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
Champlain Valley Physicians Hospital Medical Center, Plattsburgh, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
North Shore Radiation Oncology, Setauket, New York, United States
University Hospital at State University of New York - Upstate Medical University, Syracuse, New York, United States
Riverhill Radiation Oncology, Yonkers, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Batte Cancer Center at Northeast Medical Center, Concord, North Carolina, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina, Greenville, North Carolina, 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
Trinity Cancer Care Center, Minot, North Dakota, United States
Akron General Medical Center, Akron, Ohio, United States
Akron City Hospital, Akron, Ohio, United States
Cancer Center at Christ Hospital, Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Parma Community General Hospital, Parma, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, 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
St. John Health System, Tulsa, Oklahoma, United States
CCOP - Oklahoma, Tulsa, Oklahoma, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Mercy Fitzgerald Hospital, Darby, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Dale and Frances Hughes Cancer Center, East Stroudsburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania, United States
Wilkes-Barre General Hospital, Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Wellspan Health - York Cancer Center, York, Pennsylvania, United States
Roger Williams Medical Center, Providence, Rhode Island, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital, Jackson, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Arlington Cancer Center, Arlington, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Wilford Hall Medical Center, Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center, Saint George, Utah, United States
University of Utah Health Sciences Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
RMH Regional Cancer Center, Harrisonburg, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Bon Secours - St. Mary's Hospital, Richmond, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, 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
Deaconess Medical Center, Spokane, Washington, United States
Yakima Valley Memorial Hospital, Yakima, Washington, United States
Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Southern Wisconsin Radiotherapy Center, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, 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
All Saints Cancer Center at All Saints Healthcare, Racine, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Clinique Sainte Elisabeth, Namur, , Belgium
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, 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
Ottawa Regional Cancer Centre, Ottawa, Ontario, 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
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Aarhus University Hospital - Aarhus Sygehus, Aarhus, , Denmark
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Contact Details
Name: Vincent G. Gregoire, MD, PhD
Affiliation: Cliniques universitaires Saint-Luc
Role: STUDY_CHAIR
Name: Sharon A. Spencer, MD
Affiliation: University of Alabama at Birmingham
Role: STUDY_CHAIR
Name: Samy El-Sayed, MD, FFR, FRCR, FRCP
Affiliation: Ottawa Regional Cancer Centre
Role: STUDY_CHAIR
Name: Esat M. Ozsahin, MD, PhD
Affiliation: Centre Hospitalier Universitaire Vaudois
Role: STUDY_CHAIR
Name: Cai Grau, MD
Affiliation: Aarhus Universitetshospital - Aarhus Sygehus
Role: STUDY_CHAIR
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