Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1 year recurrent free survival rate
研究概览
简要总结
To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.
详细描述
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: RD) for Gemcitabine or S-1 after hemihepatectomy using Continuous Reassessment Method (CRM) analysis and decided the recommend doses. Note: In the former study, the investigators decided that tolerable ratio of Dose Limiting Toxicity (DLT) would be less than 10%.
Herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biliary tract cancer (BTC) (>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma
- •R0 or R1 resection
- •no obvious recurrent lesion
- •20 years old or more
- •Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1
- •The patient underwent no other treatment than surgery for BTC
- •Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min
- •The patient can intake drugs per os.
- •From 4 to 12 weeks after the surgery
- •Written informed consent
排除标准
- •Existence of active double cancer
- •The patient suffered from severe drug allergy
- •Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- •Any active infections exist.
- •Severe mental disorder
研究组 & 干预措施
Gemcitabine group
1000mg/m2, day 1 every 2 weeks
干预措施: Gemcitabine (Drug)
S-1 group
80mg/m2/day, day 1-28, every 6 weeks
干预措施: S-1 (Drug)
结局指标
主要结局
1 year recurrent free survival rate
时间窗: One year
Duration: From randomization to evidenced recurrence or death. Rate: Number of patients with evidenced recurrence or death / number of total patients. 1 year recurrent free survival rate: recurrent free survival rate at one-year from the randomization
次要结局
- Two-year recurrent free survival rate(Two years)
- Two-year overall survival rate(Two years)
- Completion rate of the protocol treatment(6 months)
- Dose intensity of anti-tumor drugs(6 months)
- Rate and grade of adverse events or adverse drug reactions(6 months)
- Duration of recurrent free survival(an expected average of 2 years)
- One-year overall survival rate(One year)
- Duration of overall survival(an expected average of 3 years)