Know Cancer

forgot password

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
Not Enrolling
Carcinoma of Unknown Primary

Thank you

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)


- 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

- 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

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


- 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

- 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



- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- Concurrent chemotherapy allowed

Endocrine therapy

- Not specified


- Not specified


- See Disease Characteristics


- No other prior therapy for carcinoma of unknown primary except neck dissection

Type of Study:


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


United States: Federal Government

Study ID:




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



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