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Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer — DREXNECK  

Head and Neck Cancer Clinical Trial

Official title:
Induction Chemotherapy With Taxotere, Cisplatin and 5-Fluorouracil Followed by Concomitant Cetuximab and Radiation for Locoregionally Advanced Squamous Cell Cancer of the Head and Neck: A Phase II Trial

Clinical Trial Summary

More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes.

Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen.

Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.

Clinical Trial Description

Patients will be given two cycles of induction chemotherapy with Cisplatin, Docetaxel and Fluorouracil. This will be followed by six weeks of radiation therapy along with Cetuximab. Patients will get two more cycles of chemotherapy with the same agents after the completion of radiation therapy course. Patients will be watched very closely during the trial period, with close follow up of treatment responses and monitoring of any adverse effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01467115
Study type Interventional
Source Drexel University
Contact
Status Completed
Phase Phase 2
Start date March 2010
Completion date October 7, 2014
View Details
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