Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.
Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and
loco-regional recurrence frequently occurs. Efforts have been made to improve response rates
and survival and different therapeutic regimens including concurrent chemo-radiotherapy or
sequential chemo-radiotherapy have been developed.
To further increase the outcome of patients with locally advanced SCCHN effective new
treatments with minimal toxicities are needed. Molecular targeted agents, which do not
demonstrate overlapping toxicities with commonly used chemotherapy agents, have therefore
been investigated. The EGFR is widely expressed at high levels in SSCHN and is associated
with poor prognosis.
Cetuximab has already been investigated in combination with radiotherapy or chemotherapy in
patients with head and neck cancer. The immunoradiotherapy was well tolerated with most of
the side effects related to the high dose irradiation. The most common side effects are
mucositis and dysphagia. Additionally, skin reactions appear sometimes more frequently in
cetuximab administration. Grade 3 to 4 infusion reactions were observed in 3% of the
patients treated with cetuximab. Based on the current promising results with RCT in patients
with locally advanced head and neck cancer and clinical results with EGFR-antibodies plus
RT, the present study was primarily designed to define the acute grade 3/4 toxicity.
We expect to show effective results in reducing the risk of distant metastasis, with
administration of an additional six month adjuvant cetuximab treatment, in patient with
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.
any toxicities occurring within 90 days post radiation start
Wilfried Budach, Prof. Dr.
Department of Radiotherapy and Radiological Oncology