NCT03121313

Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+

A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Squamous Cell Carcinoma of Oral Cavity

Interventions

Type	Name	Description
DRUG	tegafur-uracil

Timeline

• Start date: 2015-02-26
• Primary completion: 2020-05-11
• Completion: 2020-05-11
• First posted: 2017-04-20
• Last updated: 2019-02-12

Locations

1 site across 1 country: Taiwan