Clinical Trial: A Study of High-Risk Oral Cavity Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
Brief Summary:
Objectives:
- To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment.
- 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 Summary:
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.
Sponsor: National Health Research Institutes, Taiwan
Current Primary Outcome: 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. [ Time Frame: 7 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Physical examinations, lab abnormality and other toxicities graded by the NCI Common Toxicity Criteria will be examined to evaluate safety profiles of the study treatments. [ Time Frame: 7 years ]
Original Secondary Outcome: Same as current
Information By: National Health Research Institutes, Taiwan
Dates:
Date Received: July 7, 2009
Date Started: June 2007
Date Completion:
Last Updated: February 23, 2015
Last Verified: July 2009
