NCT00251381

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

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: Trial Form Support S.L. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oropharyngeal Neoplasms

Interventions

Type	Name	Description
DRUG	Cetuximab

Timeline

• Start date: 2005-11-01
• Completion: 2009-11-01
• First posted: 2005-11-10
• Last updated: 2006-10-26

Locations

18 sites across 1 country: Spain