Medical College of Wisconsin
This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).
Patients with surgically resectable HPV-negative HNSCC with no prior history of head and neck radiation and a life expectancy of at least 12 months will be enrolled. Patients will undergo pre-radiation pembrolizumab for two cycles followed by pre-operative radiotherapy and two additional cycles of pembrolizumab. Radiation will be given to a total dose of 35 Gy in 5 fractions to gross disease, followed by response-directed surgery approximately eight weeks after completion of radiation. Patients randomized to ENI will concurrently receive 27 Gy in 5 fractions to elective nodal regions during r…
Inclusion Criteria: * Patients 18 years or older. * Patients with surgically resectable squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx. Resectability will be determined by the treating surgeon. Patients must have locoregionally advanced disease defined by clinical T3-4 staging and/or clinical node positive staging. * A CPS score of at least 1 on initial biopsy. * Zubrod, or Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Pregnancy. It is not known what effects this treatment has on human pregnancy or development of the…
All patients will undergo induction with pembrolizumab (200 mg) given intravenously every three weeks for two cycles prior to radiation and two cycles after radiation.
All patients will receive 7 Gy daily for 5 fractions to gross disease.
Patients receiving ENI will be treated to 5.4 Gy daily to the elective nodal basins for 5 fractions concurrent with treatment to gross disease.
Patients will be scheduled for surgery at ten weeks (-7 days) after radiation to allow for maximal tumor regression and healing of any radiation-related mucositis. Surgical resection will be tailored to the treatment response.
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