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RTOG 1016

Title RTOG 1016: Phase III Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Therapeutic Area Head and Neck Cancer, Oropharyngeal Cancer
Principal Investigator Miriam O’Leary, MD
Min Age 18 Years
Gender Both
Contact Katie Singer
More Information


This research study involves the comparison of two standard plans for radiation and chemotherapy for people with head and neck cancer that may be positive for the Human Papillomavirus (HPV). The purpose of this study is to compare the effects, good and/or bad, of two standard plans for radiation/chemotherapy for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. These two plans may be comparable in treating cancer, but radiation and cetuximab may result in less severe side effects. This study is being done in patients whose head and neck cancer was caused by Human Papillomavirus Virus (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.

Study Details

Inclusion Criteria

  • Diagnosed with cancer of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
  • The cancer has been determined to be caused by the HPV virus.
  • Adequate kidney, liver, and bone marrow function

Exclusion Criteria

  • Not willing to provide tumor tissue to be tested for HPV
  • Have received previous chemotherapy drugs for this cancer
  • Have an active infection

Study Requirements

Participants' tumor tissue will be tested for p16, a test that shows that the tumor is caused by the Human Papillomavirus (HPV). This tissue test is required for this study. If the test is negative, that person will not be able to participate in this study. Eligible participants will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. Group 1 participants will receive radiation therapy for about 6 weeks and cisplatin on days 1 and 22 during radiation.

Group 2 participants will receive a dose of cetuximab a week before radiation therapy, and if they tolerate cetuximab well, will receive cetuximab once a week during the 6 weeks of radiation therapy and once after radiation therapy, for a total of 8 weeks of treatment.

Participants in the study will receive intensity modulated radiation therapy (IMRT). IMRT is a form of radiation in which radiation beams are designed to avoid important normal parts of the body, such as salivary glands. The study doctor also may decide to use a technique called image guided radiation therapy (IGRT). The purpose of IGRT is to give radiation treatment more accurately to the tumor while decreasing the radiation to normal tissues. 

All participants will be asked to visit the office for follow up at 1 and 3 months from the end of treatment, then every 3 months through year 2, every 6 months for 3 years, then once a year for their lifetimes.