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A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma

Oral Cancer Clinical Trial

Official title:
A Phase II Study of Neoadjuvant Bio-chemotherapy With Cetuximab, Paclitaxel, and Cisplatin (CPC) Followed by Cetuximab-based Concurrent Bio-radiotherapy in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)

Clinical Trial Summary

Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.

Clinical Trial Description

Patients with high-risk, locally advanced (TxN2b~3 or T4N0~3, M0) OSCC will be eligible. To detect an interested objective response rate (p1) of 80% versus a non-interested response (p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test), including the estimated dropout rate of 10%, a total of 47 patients will be recruited. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00933387
Study type Interventional
Source National Health Research Institutes, Taiwan
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date November 2013
View Details
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