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
Completed · Phase 2
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT00084318
- Run by
- Radiation Therapy Oncology Group
- People needed
- 238
- Starts
- 2004-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mobile Infirmary Medical Center — Mobile, Alabama, United States
- Arizona Oncology Services Foundation — Phoenix, Arizona, United States
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn — Scottsdale, Arizona, United States
- Mayo Clinic Scottsdale — 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
- Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
- University of California Davis Cancer Center — Sacramento, California, United States
- Mercy General Hospital — 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
- University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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