Comparing Every Three Week Versus Weekly Cisplatin with Radiotherapy for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (NRG-HN009)

September 15 2022

NRG-HN009: Randomized Phase II/III Trial of Radiation with Cisplatin (100 mg/m2) Every Three Weeks Versus Radiation with Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NRG-HN009 is a Phase II/III trial designed to compare the two most common radiation and cisplatin treatment plans for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN): 70 Gy radiation with 100 mg/m2 cisplatin every three weeks versus 40 mg/m2 cisplatin weekly. These regimens will be tested in both HPV+ and HPV- cohorts. Cohort 1 of the NRG-HN009 study will include patients with non-oropharyngeal cancer (OPC) or p16-negative OPC, whereas Cohort 2 will include patients with p16-positive OPC or cancer of unknown primary (CUP).

This stratification between study cohorts is important because patients who have either non-OPC or p16-negative OPC (Cohort 1) are typically older with more significant co-morbidities and may have less capacity or tolerance for full-course chemoradiation regimens. On the other hand, patients with p16-positive OPC or CUP (Cohort 2) are often younger with fewer medical co-morbidities and a significant opportunity to achieve long-term quality of life.

“By including both HPV+ and HPV- patients, we have the opportunity to assess potential impact on survival outcomes and toxicity profiles in these distinct head and neck cancer populations thereby possibly influencing a standard of care recommendation,” stated Paul M. Harari, MD, FASTRO, of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health and Principal Investigator of the NRG-HN009 trial.

NRG-HN009 will primarily be assessing acute toxicity (Phase II) and overall survival (Phase III) between treatment arms on both cohorts. Previous trial data has already indicated that head and neck radiation combined with concurrent cisplatin causes significant overall toxicity for patients. The results of this trial could establish non-inferiority in survival and improvement in toxicity and quality of life outcomes for patients receiving radiation with weekly cisplatin or confirm the every three week cisplatin schedule as standard of care. These results have the potential to influence global practice and future clinical trial designs for locoregionally advanced SCCHN.

This clinical trial is currently active and accruing patients.

Learn more about this trial at

Protocol documents and materials are located on the CTSU website

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