Accelerated Modulated Fractionation (SIB-IMRT) for Head and Neck District

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Nowadays the association between radiotherapy and the anti- Epidermal Growth Factor Receptor (anti-EGFR) monoclonal antibody Cetuximab represents a valid option in the treatment of head and neck locally advanced squamous neoplasm and, particularly, of oropharynx carcinoma. Up to date we have only indirect comparison with the standard curative treatment (i.e. concurrent radiochemotherapy) and the preliminary data show equivalent efficacy of both regimens. For this reason, concurrent Cetuximab and radiotherapy is administered in patients not eligible to chemoradiotherapy. The introduction of Cetuximab has been associated to new kind of toxicities, especially cutaneous, that have increasingly reported.

The aim of our study is to improve the toxicity/benefit ratio in patients receiving concurrent radiotherapy and cetuximab for locally advanced head and neck neoplasm. Hence, this improvement could be achieved by modulating radiation therapy dose per fraction following Cetuximab pharmacokinetics.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Cetuximab

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.