Clinical Trial: Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
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 Complementa
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 Summary:
- 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.
Sponsor: Trial Form Support S.L.
Current Primary Outcome: 1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.
Original Primary Outcome: Same as current
Current Secondary Outcome: Toxicity and safety of treatment will be evaluated using the Common Toxicity Criteria (CTC) of the NCI, version 3.0.; and late toxicity from radiotherapy, using RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Original Secondary Outcome: Same as current
Information By: Trial Form Support S.L.
Dates:
Date Received: November 9, 2005
Date Started: November 2005
Date Completion: November 2009
Last Updated: October 25, 2006
Last Verified: October 2006
