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Table 1 Key inclusion and exclusion criteria

From: Prospective study evaluating dynamic changes of cell-free HPV DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment

Key inclusion criteria Key exclusion criteria
Patients must be at least 18 years of age Unequivocal demonstration of distant metastatic disease
Pathologically confirmed HPV + OPC1 Non-HPV16/18 subtype
Subjects with AJCC (8th edition, 2018) N1 (if single lymph node must be \(\ge\) 3 cm), N2-N3 nodal disease or T3-T4 primary tumor N2-3 (or nodal conglomerate \(\ge\) 6 cm)
Measurable disease by RECIST 1.1 criteria  > 20 pack year smoking history
No previous radiation or chemotherapy for head and neck cancer HPV18 subtype
No complete surgical resection for head and neck cancer Unidentifiable primary site
ECOG performance status 0–1 Intercurrent medical illness which would impair patient tolerance to therapy or limit survival
Normal organ function History of HIV, active hepatitis B or hepatitis C
  1. 1Defined by p16 positivity by immunohistochemistry with confirmation with HPV PCR confirming HPV subtype