Clinical trialNCT00084318CompletedPhase 2Interventional

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck

SponsorRadiation Therapy Oncology GroupEnrollment238Head and Neck Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jeffrey N. Myers, MD, PhD, FACS
M.D. Anderson Cancer Center
Study Chair
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Merrill S. Kies, MD
M.D. Anderson Cancer Center
Study Chair
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Paul M. Harari, MD
University of Wisconsin, Madison
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

160 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Auburn Radiation Oncology
Auburn, California, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
Ccop - Bay Area Tumor Institute
Oakland, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Mercy General Hospital
Sacramento, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
Ccop - Christiana Care Health Services
Newark, Delaware, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Ccop - Mount Sinai Medical Center
Miami Beach, Florida, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Saint Anthony'S Hospital at Saint Anthony'S Health Center
Alton, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Cancer Institute at St. John'S Hospital
Springfield, Illinois, United States

120 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cetuximab →Cisplatin →Docetaxel →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2004
Primary completion: 31 Mar 2009
Completion: 31 Dec 2016
Last update posted: 12 Dec 2018
Registered enrollment: 238
Registry id: NCT00084318

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.