PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial

Inclusion criteria

• Age > 18 years;
• Written informed consent;
• Squamous carcinoma of the hypopharynx, larynx and oral cavity;
• Clinical stage I-IVa according to the VIII edition of AJCC staging system
• Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines

Exclusion criteria

• Relapsing or metastatic disease
• Locally advanced disease not amenable to curative intent treatment
• Previous local or systemic treatment for head and neck cancer
• Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study
• Psychiatric disorder or known substance abuse
• Concomitant immunosuppressive treatment
• Concomitant immunostimulant treatment
• Chronic inflammatory disease
• Autoimmune disease
• Major surgery in the previous year
• History of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol.
• Positive serum pregnancy test for women of childbearing age. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.