A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

Summary

Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled in this study. Patients are treated with standard chemoradiation in combination with concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control rate. * Trial with medicinal product * Trial with radiotherapy

Timeline

Start

2011-09-19

Primary completion

2017-10-25

Completion

2017-10-25

Publications

• de Galiza Barbosa F, Riesterer O, Tanadini-Lang S, Stieb S, Studer G, Pruschy M, Huber GF, Huellner MW, Stolzmann P, Veit-Haibach P. Evaluation of 18F-FDG PET/CT as an early imaging biomarker for response monitoring after radiochemotherapy using cetuximab in head and heck squamous cell carcinoma. Head Neck. 2020 Feb;42(2):163-170. doi: 10.1002/hed.25975. Epub 2019 Nov 9.

Drugs

Indications