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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Squamous Cell Carcinoma of Oral Cavity

Intervention / Treatment
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* Drug: tegafur-uracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have histologically confirmed squamous cell carcinoma with primary site in the oral cavity. Patient must have no distant metastasis in the pre-adjuvant radiotherapy evaluation. Patient must have received surgical treatment with pathologically documented extracapsular spreading of lymph node. Patient must have no CTCAE 4.0 grading≧2 acute adverse events from previous definite treatment at enrollment. Patient must can be enrolled within 1 to 3 months after definite treatment. Age between 20 and 70 years old; Patient must have ECOG performance status score 0 or 1; Patient must have adequate hematopoietic function which is defined as below: white blood cell (WBC) ≥ 4,000/mm3; platelet count ≥ 100,000/mm3; absolute neutrophil count (ANC) ≥ 1,500/mm3; Patients must have adequate hepatic function which is defined as below: serum bilirubin level < 1.5 mg/dl; sGOT and sGPT < 2.5 x ULN; serum creatinine level < 1.5 x ULN; All women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study medication; Patient with childbearing potential must agree to use a reliable contraceptive method during their participation in the study; Patient must have the ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Patient who has distant metastasis; Patient who has serious concomitant illness which might be aggravated by chemotherapy; Other malignancy within 5 years prior to study entry with exception of curative treated basal or squamous cell skin cancer or cervical carcinoma in situ. Female patient who is pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance<br>Eligible patient will be given maintenance tegafur-uracil for one year. Dose of tegafur-uracil will be based on patient's body surface area (BSA): BSA < 1.5 m2: tegafur-uracil 300 mg/day (1 capsule three times a day) BSA ≥ 1.5 m2: tegafur-uracil 400 mg/day (2 capsules twice a day) Tegafur-uracil will be started after patient has complete the adjuvant radiotherapy and been enrolled into the study. | Drug: tegafur-uracil<br> <br> * Other names: UFUR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 2-year distant failure rate | the 2-year distant failure rate calculated from the date of surgery will be measured | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 2-year locoregional failure rate. | the 2-year locoregional failure rate calculated from the date of surgery will be measured. | 2 years | 
| the 2-year overall survival (OS) rate | the 2-year overall survival rate calculated from the date of surgery will be measured | 2 years | 
| the 2-year progression-free survival (PFS) rate | the 2-year progression-free survival rate calculated from the date of surgery will be measured. | 2 years | 
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tegafur-uracil, distant metastasis, oral cavity cancer