Clinical Trial ECOGTHNR1016
Title
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator(s)
Details
- Protocol No. ECOGTHNR1016
- Open Date: 09/25/2012
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival
- Disease Sites: Head/Neck
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
- Drugs: Cetuximab; Cetuximab (Erbitux); Cisplatin
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: 01302834
- Secondary Protocol No: RTOG 1016
Description
Participants are being asked to take part in this study because they have head and neck cancer that may be positive for the HumanPapillomavirus (HPV).The purpose of this study is to compare the effects, good and/or bad, of two standard treatments for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. The two treatments may be comparable in treating cancer, but radiation and cetuximab may result in less severe side effects. Cisplatin is a classic chemotherapy drug. Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions. Radiation and cetuximab may result in less severe side effects. However, it is unknown whether it is equally effective as radiation and cisplatin for this type of cancer. This study is being done in patients whose head and neck cancer was caused by Human Papillomavirus (HPV). Some studies have found that patients with HPV positive oropharynx cancer have a better response to treatment and live longer. Thus, this study aims to see if treatment with radiation plus cetuximab has less side effects and is as effective as radiation plus cisplatin.