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)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Carcinoma of Unknown Primary
Female
Carcinoma of Unknown Primary
Trial Information
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)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Principal Investigator
Vincent G. Gregoire, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Cliniques universitaires Saint-Luc
Authority:
United States: Federal Government
Study ID:
EORTC-24001-22005
NCT ID:
NCT00047125
Start Date:
July 2002
Completion Date:
Related Keywords:
- Carcinoma of Unknown Primary
- newly diagnosed carcinoma of unknown primary
- squamous cell carcinoma of unknown primary
- Carcinoma
- Carcinoma, Squamous Cell
- Neoplasm Metastasis
- Neoplasms, Unknown Primary
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| Bloomington Hospital | Bloomington, Indiana 47402 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Marshfield Clinic | Marshfield, Wisconsin 54449 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Mount Diablo Medical Center | Concord, California 94524-4110 |
| California Cancer Center | Fresno, California 93720 |
| Saint Agnes Cancer Center | Fresno, California 93720 |
| Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| O'Connor Hospital | San Jose, California 95128 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Florida Radiation Oncology Group | Orange Park, Florida 32073 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| Sarasota Radiation and Medical Oncology Center | Sarasota, Florida 34233 |
| Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
| Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
| Maine Medical Center | Portland, Maine 04102 |
| Anne Arundel Oncology Center | Annapolis, Maryland 21401 |
| Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
| Harbor Hospital Center | Baltimore, Maryland 21225 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| McLaren Regional Cancer Center | Flint, Michigan 48432 |
| Marquette General Hospital | Marquette, Michigan 49855 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
| John F. Kennedy Medical Center | Edison, New Jersey 08818 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| Community Medical Center | Toms River, New Jersey 08755 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| Akron General Medical Center | Akron, Ohio 44302 |
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
| Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Dixie Regional Medical Center | Saint George, Utah 84770 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Green Mountain Oncology Group | Rutland, Vermont 05701 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Southern Wisconsin Radiotherapy Center | Madison, Wisconsin 53713 |
| Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
| Columbia Hospital | Milwaukee, Wisconsin 53211 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Naval Medical Center - San Diego | San Diego, California 92134-3202 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
| Bay Medical Center | Panama City, Florida 32401 |
| Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
| MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Atlantic City Medical Center | Pomona, New Jersey 08240 |
| Associated Radiologists, P.A. | Warren, New Jersey 07059 |
| St. John Health System | Tulsa, Oklahoma 74104 |
| University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
| Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| DCH Cancer Treatment Center | Tuscaloosa, Alabama 35401 |
| Radiation Medical Group, Incorporated | San Diego, California 92101 |
| Hospital of St. Raphael | New Haven, Connecticut 06511 |
| Holmes Regional Medical Center | Melbourne, Florida 32901-3276 |
| Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
| Community Regional Cancer Care | Indianapolis, Indiana 46219 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| William Beaumont Hospital - Troy | Troy, Michigan 48098 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
| Valley Hospital | Ridgewood, New Jersey 07450 |
| Radiation Oncology Associates of Albuquerque | Albuquerque, New Mexico 87109 |
| Finger Lakes Radiation Oncology Center | Clifton Springs, New York 14432 |
| Riverhill Radiation Oncology | Yonkers, New York 10701 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
| Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| RMH Regional Cancer Center | Harrisonburg, Virginia 22801 |
| Bon Secours - St. Mary's Hospital | Richmond, Virginia 23226 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
| Wellspan Health - York Cancer Center | York, Pennsylvania 17403 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
| Torrance Memorial Medical Center | Torrance, California 90505 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| 21st Century Oncology - Fort Myers | Fort Myers, Florida 33901-8082 |
| Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
| CCOP - Scott and White Hospital | Peoria, Illinois 61602 |
| Oncology Institute of Greater Lafayette | Lafayette, Indiana 47904 |
| St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
| Cancer Center at Lexington Clinic | Lexington, Kentucky 40504 |
| St. Agnes Cancer Center | Baltimore, Maryland 21229 |
| NSMC Cancer Center | Peabody, Massachusetts 01960 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Medical Center of Princeton | Princeton, New Jersey 08540 |
| Lourdes Regional Cancer Center | Binghamton, New York 13905 |
| North Shore Radiation Oncology | Setauket, New York 11733 |
| Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
| Cancer Center at Christ Hospital | Cincinnati, Ohio 45219 |
| Parma Community General Hospital | Parma, Ohio 44129 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| Cancer Institute at Virginia Mason Medical Center | Seattle, Washington 98111 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Shands Cancer Center at the University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
| William Beaumont Hospital - Royal Oak | Royal Oak, Michigan 48073-6769 |
| University Hospital at State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville, North Carolina 27858-4354 |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
| Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville, Kentucky 42431 |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
| All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
| Huntington Cancer Center at Huntington Hospital | Pasadena, California 91105 |
| St. Joseph's Regional Cancer Center | Stockton, California 95204 |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
| Ball Memorial Hospital Cancer Center | Muncie, Indiana 47303-3499 |
| Siteman Cancer Center | Saint Louis, Missouri 63110 |
| Frank C. Love Cancer Institute at St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
| Montgomery Cancer Center | Montgomery, Alabama 36106-3657 |
| Radiation Oncology Centers - Sacramento | Sacramento, California 95816 |
| Louisville Radiation Oncology Center at Caritas Regional Cancer Center | Louisville, Kentucky 40215 |
| Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
| Dale and Frances Hughes Cancer Center | East Stroudsburg, Pennsylvania 18301 |
| Wilkes-Barre General Hospital | Wilkes-Barre, Pennsylvania 18764-0001 |
| West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
