Randomized Phase II/III Trial Of Radiation With High-Dose Cisplatin (100 Mg/M2) Every 3 Weeks vs Radiation With Low-Dose Weekly Cisplatin (40 Mg/M2) For Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (Scchn) (NRG-HN009)

This study is being done to answer the following questions:

1. Does low-dose cisplatin given weekly with radiation have fewer side effects than high-dose cisplatin given every 3 weeks with radiation?
2. Can low-dose cisplatin given weekly with radiation extend life by at least the same amount of time as high-dose cisplatin given every 3 weeks with radiation?

The purpose of this study is to find out if the low-dose cisplatin given weekly is the same or better than the high-dose cisplatin given every 3 weeks.

This study has two parts. In the first part, doctors will try to learn the answer to question #1 above. If the answer shows that low-dose cisplatin given weekly has fewer side effects, then the study will go on to the second part, and doctors will try to answer question #2.

What is the usual approach to advanced head and neck cancer?

The usual approach is defined as care most people get for your type of head and neck cancer. The usual approach for patients who are not in this study is treatment with radiation therapy combined with the chemotherapy drug cisplatin. Cisplatin is a drug approved by the Food and Drug Administration (FDA) to treat head and neck cancer. Cisplatin can be given at different doses and at different times during radiation, but the most common way to give cisplatin is either as a high-dose every 3 weeks or a low-dose weekly during radiation. For patients who get the usual approach for this cancer, about 20-70 out of 100 are free of cancer after 5 years depending on the location of cancer and other medical conditions.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

• Age 18 years of age or older
• Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary
• Additional eligibility in protocol

• Oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary
• Definitive clinical or radiologic evidence of distant metastatic disease
• Prior exposure to cisplatin
• Women who are pregnant/breastfeeding
• Additional ineligibility in protocol

For additional information, please visit: https://www.clinicaltrials.gov/ct2/show/NCT05050162