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)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the overall response rate after completion of the assigned treatment.
J Y Chang, M.D.
National Health Research of Institutes
Taiwan: Institutional Review Board