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

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00251381
Study type Interventional
Source Trial Form Support S.L.
Contact Jaume Graupera
Phone 34 93 185 02 00
Email jaume.graupera@trialformsupport.com
Status Recruiting
Phase Phase 2
Start date November 2005
Completion date November 2009
View Details
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