Accelerated Modulated Fractionation (SIB-IMRT) for Head and Neck District (FAMOSO)
Carcinoma of the Head and Neck
About this trial
This is an interventional treatment trial for Carcinoma of the Head and Neck
Eligibility Criteria
Inclusion Criteria:
- Patients with histological proof of locally advanced squamous carcinoma of oropharynx, larynx, hypopharynx (stage III and Iva)
- Overexpression of EGFR (>50%)
- Patients previously considered non-eligible for curative radio-chemotherapy for clinical reasons.
- Performance Status (ECOG) ≤ 2
- Age ≥ 18 years
- Possibility of correct administration of treatment
- Written informed consent
Exclusion Criteria:
- Distant metastases
- Oral cavity or rhinopharynx neoplasm
- Need of cutaneous bolus
- Previous treatments on head and neck district
- Collagenopathies or other severe systemic disease
- Severe cardiopathies or myocardial infarction in the previous 12 months, serious hepatopathies or other diseases with heavy impact on general conditions.
- Psychiatric disorders or other conditions preventing from expressing informed consent.
Sites / Locations
- Division of Radiotherapy European Institute of OncologyRecruiting
Arms of the Study
Arm 1
Experimental
Arm 1
Radiotherapy treatment associated with concurrent Cetuximab administration. Patients candidate to curative concurrent Cetuximab and Radiotherapy are eligible for this study. After expressing written informed consent, patients will perform CT simulation. Then an IMRT-SIB (Simultaneous Integrated Boost) treatment plan will be elaborated and deliver the following Cetuximab pharmacokinetic: Length: 6 weeks; 1 fraction daily (From Monday to Friday) 30 Total Fractions (5 per week, 6 weeks of treatment). Cetuximab will be administered weekly from a week before starting radiotherapy until the end of treatment for 7 subsequent administration accordingly to the standard schedule (1 before and 6 during radiotherapy).