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Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

Head and Neck Cancer Clinical Trial

Official title:
Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities

Clinical Trial Summary

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

Clinical Trial Description

Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation. Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins. Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen. Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample. Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00904345
Study type Interventional
Source University of Michigan Rogel Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date April 2009
Completion date December 2020
View Details
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