A Phase II Study of Less Intensive Treatment for Head and Neck Cancer

Full Title

A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer(NRG-HN002) (CIRB)

Purpose

Treatment for head and neck cancers typically includes chemotherapy and radiation therapy. It can be quite intensive and cause uncomfortable side effects. In this study, researchers are comparing the effectiveness of two less intensive treatment regimens for nonsmoking patients with oropharyngeal cancers that produce high amounts of a protein called p16. It is possible that this group of patients may be able to be treated effectively with lower doses of chemotherapy and radiation therapy.

Patients will be randomly assigned to one of two groups. One group will receive radiation therapy five days a week for six weeks and the chemotherapy drug cisplatin intravenously (by vein) once a week for six weeks. The second group will receive radiation therapy alone (the same total dose as group one), given according to an accelerated schedule: six treatments a week for five weeks. Researchers will compare the two groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have squamous cell carcinoma of the oropharynx (tonsils, base of the tongue, soft palate, or walls of the oropharynx) that is positive for p16.
  • Patients must be nonsmokers or not have a smoking history that exceeds 10 pack-years.
  • Patients may not have had prior chemotherapy or radiation therapy for their oropharyngeal cancer.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. C. Jillian Tsai at 631-623-4268.

Protocol

16-1242

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators