AzTrials
AzTrials

Carcinoma of Unknown PrimaryPhase 3NCT00047125

Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor

A Phase 3 study testing radiation therapy in people with Carcinoma of Unknown Primary, run by European Organisation for Research and Treatment of Cancer - EORTC at 262 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Carcinoma of Unknown Primary
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
262 sitesin 6 countries
Study dates
Jul 2002to Jul 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

262 sites in 6 countries.

262 sites in 6 countries

United States237 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44304

  • Radiation Oncology Associates of Albuquerque

    Albuquerque, New Mexico, 87109

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • St. John's Cancer Center at St. John's Medical Center

    Anderson, Indiana, 46016

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0010

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21215-1290

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Lourdes Regional Cancer Center

    Binghamton, New York, 13905

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05405-0075

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Cancer Center at Christ Hospital

    Cincinnati, Ohio, 45219

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Finger Lakes Radiation Oncology Center

    Clifton Springs, New York, 14432

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Medical Center/John B. Amos Community Cancer Center

    Columbus, Georgia, 31901

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07019

  • Dale and Frances Hughes Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • McLaren Regional Cancer Center

    Flint, Michigan, 48532-3685

  • 21st Century Oncology - Fort Myers

    Fort Myers, Florida, 33901-8082

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • Shands Cancer Center at the University of Florida Health Science Center

    Gainesville, Florida, 32610-0385

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502-1628

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • RMH Regional Cancer Center

    Harrisonburg, Virginia, 22801

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46206-1367

  • Community Regional Cancer Care

    Indianapolis, Indiana, 46219

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Florida Radiation Oncology Group

    Jacksonville, Florida, 32207

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • Oncology Institute of Greater Lafayette

    Lafayette, Indiana, 47904

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Cancer Center at Lexington Clinic

    Lexington, Kentucky, 40504

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1714

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology Center at Caritas Regional Cancer Center

    Louisville, Kentucky, 40215

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901-3276

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36607

  • Montgomery Cancer Center

    Montgomery, Alabama, 36106-3657

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital Cancer Center

    Muncie, Indiana, 47303-3499

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-5671

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Hospital of St. Raphael

    New Haven, Connecticut, 06511

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8040

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112-2699

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center - Philipps Ambulatory Care Center

    New York, New York, 10003

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Frank C. Love Cancer Institute at St. Anthony Hospital

    Oklahoma City, Oklahoma, 73102

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7521

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806-2134

  • Bay Medical Center

    Panama City, Florida, 32401

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Huntington Cancer Center at Huntington Hospital

    Pasadena, California, 91105

  • NSMC Cancer Center

    Peabody, Massachusetts, 01960

  • CCOP - Scott and White Hospital

    Peoria, Illinois, 61602

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Abramson Cancer Center at University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141-3098

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901-1490

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Atlantic City Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Medical Center of Princeton

    Princeton, New Jersey, 08540

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908-4735

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Bon Secours - St. Mary's Hospital

    Richmond, Virginia, 23226

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0058

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • Radiation Oncology Centers - Sacramento

    Sacramento, California, 95816

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Radiation Medical Group, Incorporated

    San Diego, California, 92101

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • O'Connor Hospital

    San Jose, California, 95128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Radiation and Medical Oncology Center

    Sarasota, Florida, 34233

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Cancer Institute at Virginia Mason Medical Center

    Seattle, Washington, 98111

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Shore Radiation Oncology

    Setauket, New York, 11733

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110-0250

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • St. Joseph's Regional Cancer Center

    Stockton, California, 95204

  • University Hospital at State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Fox Chase Cancer Center at St. Francis Medical Center

    Trenton, New Jersey, 08629

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • DCH Cancer Treatment Center

    Tuscaloosa, Alabama, 35401

  • Associated Radiologists, P.A.

    Warren Township, New Jersey, 07059

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Wilkes-Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764-0001

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Riverhill Radiation Oncology

    Yonkers, New York, 10701

  • Wellspan Health - York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada20 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Northwestern Ontario Regional Cancer Care

    Thunder Bay, Ontario, P7B 6V4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Clinique Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital - Aarhus Sygehus

    Aarhus, DK-8000

Other trials in Denmark

Netherlands1 site

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

Other trials in Netherlands

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
radiation therapy
Keywords
newly diagnosed carcinoma of unknown primary, squamous cell carcinoma of unknown primary
Medical subject headings
Neoplasms, Unknown Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

Study groups in NCT00047125
Study groupRoleWhat they receive
Selective irradiationExperimentalIrradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).
Receives: Radiation: radiation therapy
Extensive irradiation + ipsilaterals levelsActive comparatorIrradiation on the whole mucosa of the larynx, hypopharynx, oropharynx and nasopharynx, and on both sides of the neck (levels I -V) up to a prophylactic dose of 50 Gy (25 x 2 Gy in 5 week).Irradiation of the ipsilateral level I - V of the neck should continue with an additional 10 Gy boost for a total dose of 60 Gy (30 x 2 Gy in 6 weeks).
Receives: Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Primary completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047125
Sponsor's protocol ID
EORTC-24001-22005
Other IDs
EORTC-24001, EORTC-22005, DAHANCA-EORTC-24001, CAN-NCIC-EORTC-24001, RTOG-EORTC-24001
Status last verified
Jul 2018
First submitted
3 Oct 2002
Last updated
9 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiation therapy in people with Carcinoma of Unknown Primary, run by European Organisation for Research and Treatment of Cancer - EORTC at 262 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, Canada, Belgium, Denmark, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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