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

Primary Purpose

Carcinoma of Unknown Primary

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

radiation therapy

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring newly diagnosed carcinoma of unknown primary, squamous cell carcinoma of unknown primary

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham Comprehensive Cancer Center
Comprehensive Cancer Institute
MBCCOP - Gulf Coast
Montgomery Cancer Center
DCH Cancer Treatment Center
Foundation for Cancer Research and Education
Providence Saint Joseph Medical Center - Burbank
Mount Diablo Medical Center
City of Hope Comprehensive Cancer Center
California Cancer Center
Saint Agnes Cancer Center
Sutter Health Western Division Cancer Research Group
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Veterans Affairs Medical Center - Long Beach
USC/Norris Comprehensive Cancer Center and Hospital
Jonsson Comprehensive Cancer Center, UCLA
CCOP - Bay Area Tumor Institute
Huntington Cancer Center at Huntington Hospital
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Radiation Oncology Centers - Sacramento
Radiation Medical Group, Incorporated
Naval Medical Center - San Diego
UCSF Comprehensive Cancer Center
O'Connor Hospital
CCOP - Santa Rosa Memorial Hospital
St. Joseph's Regional Cancer Center
Torrance Memorial Medical Center
David Grant Medical Center
Memorial Hospital Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center
CCOP - Colorado Cancer Research Program, Incorporated
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Hospital of St. Raphael
Yale Comprehensive Cancer Center
CCOP - Christiana Care Health Services
Sibley Memorial Hospital
21st Century Oncology - Fort Myers
Shands Cancer Center at the University of Florida Health Science Center
Florida Radiation Oncology Group
Holmes Regional Medical Center
CCOP - Mount Sinai Medical Center
University of Miami Sylvester Cancer Center
Baptist Hospital of Miami
MD Anderson Cancer Center Orlando
Bay Medical Center
Gulf Coast Cancer Treatment Center
Sarasota Radiation and Medical Oncology Center
Tallahassee Memorial Hospital
H. Lee Moffitt Cancer Center and Research Institute
Winship Cancer Institute of Emory University
CCOP - Atlanta Regional
Medical Center/John B. Amos Community Cancer Center
Regional Radiation Oncology Center at Rome
MBCCOP - Hawaii
Northwest Community Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
CCOP - Central Illinois
Ingalls Memorial Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Lutheran General Cancer Care Center
CCOP - Scott and White Hospital
Methodist Medical Center of Illinois
St. John's Cancer Center at St. John's Medical Center
Bloomington Hospital
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Methodist Cancer Center at Methodist Hospital
Community Regional Cancer Care
Oncology Institute of Greater Lafayette
Ball Memorial Hospital Cancer Center
CCOP - Northern Indiana CR Consortium
Wendt Regional Cancer Center of Finley Hospital
St. Elizabeth Medical Center
Central Baptist Hospital
Cancer Center at Lexington Clinic
Markey Cancer Center at University of Kentucky Chandler Medical Center
James Graham Brown Cancer Center at University of Louisville
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Mary Bird Perkins Cancer Center
Tulane Cancer Center at Tulane University Hospital and Clinic
MBCCOP - LSU Health Sciences Center
CCOP - Ochsner
Maine Medical Center
Anne Arundel Oncology Center
Greenebaum Cancer Center at University of Maryland Medical Center
Greater Baltimore Medical Center and Cancer Center
Harbor Hospital Center
Sinai Hospital of Baltimore
St. Agnes Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Peninsula Regional Medical Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Cancer Research Center at Boston Medical Center
Cape Cod Hospital
Veterans Affairs Medical Center - Boston (Jamaica Plain)
NSMC Cancer Center
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Barbara Ann Karmanos Cancer Institute
Josephine Ford Cancer Center at Henry Ford Hospital
McLaren Regional Cancer Center
CCOP - Kalamazoo
Marquette General Hospital
MidMichigan Medical Center - Midland
CCOP - Beaumont
William Beaumont Hospital - Royal Oak
William Beaumont Hospital - Troy
Fairview University Medical Center - University Campus
Mayo Clinic Cancer Center
CCOP - Metro-Minnesota
Ellis Fischel Cancer Center at University of Missouri - Columbia
CCOP - Kansas City
St. Louis University Hospital Cancer Center
Siteman Cancer Center
CCOP - Cancer Research for the Ozarks
CCOP - Montana Cancer Consortium
CCOP - Missouri Valley Cancer Consortium
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
CCOP - Southern Nevada Cancer Research Foundation
Comprehensive Cancer Centers of Nevada
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Elliot Regional Cancer Center
Veterans Affairs Medical Center - East Orange
John F. Kennedy Medical Center
Monmouth Medical Center
South Jersey Regional Cancer Center
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Cancer Institute of New Jersey
Newark Beth Israel Medical Center
Atlantic City Medical Center
Medical Center of Princeton
Valley Hospital
Community Medical Center
Fox Chase Cancer Center at St. Francis Medical Center
Associated Radiologists, P.A.
Radiation Oncology Associates of Albuquerque
Lourdes Regional Cancer Center
SUNY Downstate Medical Center
New York Methodist Hospital
Finger Lakes Radiation Oncology Center
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
CCOP - North Shore University Hospital
Beth Israel Medical Center - Philipps Ambulatory Care Center
Memorial Sloan-Kettering Cancer Center
Herbert Irving Comprehensive Cancer Center at Columbia University
Champlain Valley Physicians Hospital Medical Center
James P. Wilmot Cancer Center at University of Rochester Medical Center
North Shore Radiation Oncology
University Hospital at State University of New York - Upstate Medical University
Riverhill Radiation Oncology
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Batte Cancer Center at Northeast Medical Center
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
CCOP - Southeast Cancer Control Consortium
Comprehensive Cancer Center at Wake Forest University
Trinity Cancer Care Center
Akron General Medical Center
Akron City Hospital
Cancer Center at Christ Hospital
Charles M. Barrett Cancer Center at University Hospital
Ireland Cancer Center
University Hospitals of Cleveland
Cleveland Clinic Taussig Cancer Center
CCOP - Columbus
Arthur G. James Cancer Hospital - Ohio State University
CCOP - Dayton
Parma Community General Hospital
CCOP - Toledo Community Hospital
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma University Medical Center
St. John Health System
CCOP - Oklahoma
CCOP - Columbia River Oncology Program
Abington Memorial Hospital
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
St. Luke's Hospital Cancer Center
Geisinger Medical Center
Mercy Fitzgerald Hospital
Delaware County Memorial Hospital
Dale and Frances Hughes Cancer Center
Penn State Cancer Institute at Milton S. Hershey Medical Center
Abramson Cancer Center at University of Pennsylvania Medical Center
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center
Albert Einstein Cancer Center
Allegheny General Hospital
Mercy Hospital of Pittsburgh
Western Pennsylvania Hospital
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Reading Hospital and Medical Center
Mercy Hospital Cancer Center - Scranton
Wilkes-Barre General Hospital
CCOP - MainLine Health
Wellspan Health - York Cancer Center
Roger Williams Medical Center
CCOP - Greenville
CCOP - Upstate Carolina
Rapid City Regional Hospital
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Harrington Cancer Center
Arlington Cancer Center
University of Texas Medical Branch
University of Texas - MD Anderson Cancer Center
Wilford Hall Medical Center
Joe Arrington Cancer Research and Treatment Center
University of Texas Health Science Center at San Antonio
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center
University of Utah Health Sciences Center
LDS Hospital
Green Mountain Oncology Group
Vermont Cancer Center at University of Vermont
Cancer Center at the University of Virginia
RMH Regional Cancer Center
Naval Medical Center, Portsmouth
Bon Secours - St. Mary's Hospital
Massey Cancer Center at Virginia Commonwealth University
Cancer Institute at Virginia Mason Medical Center
University Cancer Center at University of Washington Medical Center
Deaconess Medical Center
Yakima Valley Memorial Hospital
Schiffler Cancer Center at Wheeling Hospital
CCOP - St. Vincent Hospital Cancer Center, Green Bay
St. Vincent Hospital
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
Southern Wisconsin Radiotherapy Center
University of Wisconsin Comprehensive Cancer Center
CCOP - Marshfield Clinic Research Foundation
Marshfield Clinic
Community Memorial Hospital
Columbia Hospital
St. Luke's Medical Center
Veterans Affairs Medical Center - Milwaukee (Zablocki)
All Saints Cancer Center at All Saints Healthcare
Waukesha Memorial Hospital Regional Cancer Center
Cliniques Universitaires Saint-Luc
Clinique Sainte Elisabeth
Tom Baker Cancer Center - Calgary
Cross Cancer Institute
Doctor Leon Richard Oncology Centre
Saint John Regional Hospital
Newfoundland Cancer Treatment and Research Foundation
Nova Scotia Cancer Centre
Margaret and Charles Juravinski Cancer Centre
Kingston Regional Cancer Centre
Cancer Care Ontario-London Regional Cancer Centre
Ottawa Regional Cancer Centre
Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital
Northwestern Ontario Regional Cancer Care
Toronto Sunnybrook Regional Cancer Centre
Princess Margaret Hospital
CHUS-Hopital Fleurimont
Centre Hospitalier de l'Universite de Montreal
McGill University
Centre Hospitalier Universitaire de Quebec
Allan Blair Cancer Centre
Saskatoon Cancer Centre
Aarhus University Hospital - Aarhus Sygehus
Vrije Universiteit Medisch Centrum
Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Selective irradiation

Extensive irradiation + ipsilaterals levels

Arm Description

Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).

Irradiation 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).

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00047125

First Posted

October 3, 2002

Last Updated

July 6, 2018

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Radiation Therapy Oncology Group, NCIC Clinical Trials Group, Danish Head and Neck Cancer Group

1. Study Identification

Unique Protocol Identification Number

NCT00047125

Brief Title

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

Official Title

Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary (CUP)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

July 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Radiation Therapy Oncology Group, NCIC Clinical Trials Group, Danish Head and Neck Cancer Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective in treating patients who have metastases to the lymph nodes in the neck. PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor.

Detailed Description

OBJECTIVES: Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation. Compare the overall survival of patients treated with these regimens. Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens. Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens. Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (N1-2a vs N2b-3), radiation technique (2D vs 3D conformal vs intensity-modulated), and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks. Arm II: Patients undergo extensive irradiation of the neck (nasopharyngeal, oropharyngeal, hypopharyngeal, and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck) once daily 5 days a week for 6 weeks. In both arms, treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, at week 4, on the last day of therapy, and then every 3 months for 1 year. Patients are followed at day 30, every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 7 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma of Unknown Primary

Keywords

newly diagnosed carcinoma of unknown primary, squamous cell carcinoma of unknown primary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Selective irradiation

Arm Type

Experimental

Arm Description

Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).

Arm Title

Extensive irradiation + ipsilaterals levels

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

disease-free survival

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: