A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital Changhua Christian Hospital Chi Mei Medical Hospital China Medical University Hospital National Cheng-Kung University Hospital