Wednesday, May 15, 2019 Dr. Khalil Sultanem is a Radiation Oncologist working at the Jewish General Hospital at McGill University. He is involved in the Head and Neck disease site committee at CCTG and is the Co-Chair of the HN9 study. Dr. Sultanem believes the HN9 study is a unique and innovative study because it provides a possibility to replace chemotherapy, which is toxic, with immunotherapy. He also emphasizes that the HN9 is an intergroup, multi-institutional study that will provide valid, effective and safe results and may serve as a framework to lead cancer researchers in the future. CCTG HN9: Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC). NCT Registration ID (from clinicaltrials.gov): NCT03410615 The primary objectives of the HN9 study aim to estimate the efficacy (in terms of event-free survival) of 3 treatment Arms: (A) radiotherapy (RT) and cisplatin; (B) RT and durvalumab followed by adjuvant durvalumab; and (C) RT and durvalumab followed by adjuvant durvalumab and tremelimumab in patients with intermediate risk, HPV-positive, locally advanced oropharyngeal squamous cell carcinoma of the head and neck (LA-OSCC). Secondary: 1) To assess differences between arms in change in FACT-HN score from baseline to 36 months post-RT; 2) To estimate and describe the following in each of the 3 treatment arms: Locoregional control; Distant metastasis-free survival (DMFS); OS; Toxicity; Incidence of second cancer; Dysphagia; PRO-CTCAE Radiation related late toxicity; Cost effectiveness; Cost utility; and lost productivity. Tertiary: 1) Correlative Studies; 2) Event-free survival as defined by iRECIST For more information please visit the CCTG HN9 trial page.
