Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab (NICAP)

Inclusion Criteria

• Aged 18 to 75 years old;
• Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
• Stages III or IV disease
• Unresectability according to responsible surgeon or medical staff's opinion;
• Performance status 0 or 1
• Present indication for radiation therapy and chemotherapy treatment with cisplatin;
• Adequate hepatic, renal and medullar functions, indicated by:
• Life expectancy above 6 months.

Exclusion Criteria

• Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
• Presence of known distant metastasis;
• Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
• Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
• Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
• Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance;
• Active known seropositivity for HIV, hepatitis B or C
• Presence of a significant neurological or psychiatric disease, as per the investigator's judgment;
• Hypersensitivity or allergy to any of the study treatments;
• Presence of uncontrolled hypercalcemia;
• Pregnancy or breastfeeding;
• Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period;
• Participation in any clinical trial in the last 12 months.