Spots Global Cancer Trial Database for Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.

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Trial Identification

Brief Title: Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.

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.

Study ID: NCT00251381

Conditions

Oropharyngeal Neoplasms

Interventions

Cetuximab

Study Description

Brief Summary: 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.

Detailed Description: * 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.