A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the 2-year distant failure rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Maintenance
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.
干预措施: tegafur-uracil (Drug)
结局指标
主要结局
the 2-year distant failure rate
时间窗: 2 years
the 2-year distant failure rate calculated from the date of surgery will be measured
次要结局
- the 2-year locoregional failure rate.(2 years)
- the 2-year progression-free survival (PFS) rate(2 years)
- Incidence of Treatment-Emergent Adverse Events(2 years)
- the 2-year overall survival (OS) rate(2 years)