A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer
详细描述
This stage I study is designed to evaluate the appropriate dose of S-1 plus radiotherapy for patients with R0 resection of rectal cancer for stage II-III patients(AJCC 7th). To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •R0 resection of histologically proved stage II/III rectal cancer;
- •18-75 years old;
- •No previous radiotherapy or chemotherapy for rectal cancer;
- •Performance status of ECOG 0,1;
- •Adequate organ function defined as below:
- •i. WBC ≥ 4,000/mm^3 ii. ANC ≥ 1,500/mm^3 iii. Hemoglobin ≥ 10g/dL iv. Platelet ≥ 100,000/m^3 v. Total bilirubin ≤ 1.5ULN vi. AST/ALT ≤ 1.5ULN vii. Serum creatinine ≤ 1.5ULN or creatinine clearance rate ≥ 60ml/min、Urea nitrogen ≤ 1.5ULN viii. Protein in urine dipstick test<1+; if the test result >1+ ,total protein in urea must <500mg within 24 hours
- •Able to receive oral administration
- •Informed consent
排除标准
- •Hypersensitive to S-1 or its excipients
- •Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration
- •Significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- •Received any investigational drug or anti-cancer agent
- •Pregnant or lactating female or pregnancy test positive
- •Severe mental disorder
- •Judged ineligible by physicians for participation in the study due to safety concern.
研究组 & 干预措施
Chemoradiotherapy
There are four dose levels and one arm only. Level 1: S-1, 50 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 2: S-1, 65 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 3: S-1, 80 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 4: S-1, 90 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks
干预措施: Chemoradiotherapy (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 6weeks (42 days)
次要结局
- Dose Limiting Toxicities (DLTs)(6weeks (42 days))
- Quality of Life(6weeks (42 days))
研究者
Zhen-zhou Yang
Professor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University