Oral Cavity Cancer Clinical Trial
Official title:
Multicentre,A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
Objectives:
1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of
high-risk oral cavity cancer patients after curative local treatment.
2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy
Study design:
This is a multi-center randomized controlled phase II/III two-stage study.
Study endpoints:
The primary endpoint is the tumor-free survival (primary and second primary malignancies)
and the primary analysis is to compare the tumor-free survival between groups.
Type and number of patients:
Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be
enrolled.
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)
Treatment schedule:
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
chemoradiotherapy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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