Basic Clinical Radiobiology 2017
Study design • Phase III superiority study • Primary endpoint: loco-regional control rate
• Secondary endpoints: local control, regional control, time to distant metastases, overall survival, disease-free survival, disease-specific survival, acute and late morbidity • Stratification for: • Institution • Localization: hypopharynx vs oropharynx vs larynx • T-stage: T1-2 vs T3-4 • N-stage: N0-1 vs N2-3 • WHO - PS: 0-1 vs 2 • Hypoxic gene-profile: positive vs negative vs undetermined • Size: 640 patients (320 in each treatment arm) (the recruitment will continue until 200 patients are available in the hypoxic signature positive subgroup)
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