Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.

Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

This is a phase III, superiority, national, open-label, randomized, and two-arm study.

Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.

All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.

Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1

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.