Background of the study
To date, the standard treatment for squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or locally advanced larynx involves the combination of cisplatin and radiation treatment. In the last years, the treatment landscape of the head and neck cancer has greatly changed: in fact, it was suggested the potential relevance of an induction chemotherapy treatment, to be administered before the radiation therapy.
Cisplatin, the main actor of this treatment as cytotoxic agent, could be combined with other drugs such as 5-fluorouracil and docetaxel with a real benefit, while the efficacy in this setting of the anti-EGFR monoclonal antibody cetuximab was demonstrated.
Aim of the study
We therefore planned a clinical trial in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx locally advanced, the standard of care, to evaluate whether the addition of a combination chemotherapy (cisplatin + 5-fluorouracil + docetaxel) and, subsequently, a radiation therapy associated with cetuximab is better than the standard approach (cisplatin + radiation therapy). The impact of the new proposed strategy will be evaluated in terms of overall survival, but also safety profile, locoregional disease control, response rate and disease free survival.