maintenance tegafur-uracil in resected oral cavity cancer with ecs+

Conditions: Squamous Cell Carcinoma of Oral Cavity

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.

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.

Eligibility criteria:
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: 1. white blood cell (wbc) ≥ 4,000/mm3; 2. platelet count ≥ 100,000/mm3; 3. absolute neutrophil count (anc) ≥ 1,500/mm3; * patients must have adequate hepatic function which is defined as below: 1. serum bilirubin level \< 1.5 mg/dl; 2. sgot and sgpt \< 2.5 x uln; 3. 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.

Keywords: tegafur-uracil distant metastasis oral cavity cancer