NCT00934739

A Study of High-Risk Oral Cavity Cancer

Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Oral Cavity Cancer

Interventions

Type	Name	Description
DRUG	Thalidomide, Celebrex	Immediately after operation starts thalidomide (50) 4# per day and celecoxib (Celebrex)(200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy
DRUG	Cyclophosphamide, Dexamethasone	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

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-07-08
• Last updated: 2015-02-25