Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
Type and number of patients:
Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be
Sample size at the first stage is 64 patients per group and the total sample size at the end
of the second stage is 192 patients per group, assuming that the accrual rate/hazard rate =
1.33, an α=0.05 and power of 0.8 (Hypotheses: H0:θ ≦ 1.0 and Ha: θ ≧ 1.33)
Group A：standard postoperative concurrent chemoradiotherapy.
Group B：Immediately after operation starts thalidomide (50) 4# per day and celecoxib (200)
2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy.
Group C：Immediately after operation starts cyclophosphamide (50) 1# per day and
dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the tumor-free survival that is defined as the duration between the dates of operation and the date of disease recurrence.
Ruey-Long Hong, MD, PhD.
Department of Oncology, National Taiwan University Hospital
Taiwan: Department of Health