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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Radiation:
radiation therapy


Locations

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

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Netherlands,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival
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