Oropharyngeal Neoplasms Clinical Trial
Official title:
Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
- To determine the 1-year rate of locoregional disease control in the experimental arm,
using a control arm to avoid selection bias.
- To determine the 2 and 3 year rate of locoregional disease control.
- To evaluate the safety and toxicity of the combination of cetuximab and
concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary
treatment with cetuximab. Both acute and chronic toxicity will be assessed.
- To determine specific disease-free survival, event-free survival, disease-specific
survival and overall survival
- To determine acute and late toxicity
- To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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