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Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Head and Neck Cancer Clinical Trial

Official title:
Phase II Trial of Post-operative or Definitive Concurrent Radiation and Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer. The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.

Clinical Trial Description

This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01979211
Study type Interventional
Source University of Cincinnati
Contact
Status Completed
Phase Phase 2
Start date October 2013
Completion date January 19, 2022
View Details
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