Squamous Cell Carcinoma of Oral Cavity Clinical Trial
Official title:
A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
Primary Objective:
To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with
squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.
Secondary Objectives:
- To determine the 2-year locoregional failure rate.
- To evaluate the 2-year overall survival (OS) rate.
- To evaluate the 2-year progression-free survival (PFS) rate.
- To assess the safety profiles.
The primary endpoint will be 2-years distant failure rate which will be estimated by
Kaplan-Meier method with two-sided 95% confidence interval.
The secondary endpoints are described as follows:
- 2-year locoregional failure rate, 2-year PFS rate and 2-year OS rate will be estimated
by Kaplan-Meier method with two-sided 95% confidence interval.
- Safety profile: adverse events will be summarized by CTCAE. Safety parameters will only
be analyzed on the safety analysis set and be presented in frequency tabulation.
Determination of sample size:
The estimated 2-year distant failure rate for squamous cell carcinoma of oral cavity with
extracapsular spreading of lymph nodes is 26%. The 2-year distant failure rate of maintenance
treatment with tegafur-uracil in this study is expected to be 13%. Using One Proportional
Test with one-sided alpha 0.05 and power 80%, the sample size of 56 subjects will test an
effect size of 13% (i.e. 26% vs.13%). With expected dropout rate of 20%, the sample size
would be 68 subjects.
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