Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PFS of 1st line treatment
研究概览
简要总结
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).
详细描述
A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histological diagnosis of colorectal cancer. 2） Age: 18 - 75 years. 3） No prior chemotherapy 4） ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ≧3,500/mm3 and Neutrophil ≧2,000/mm
- •Hb ≧10.0 g/dl. Platelet count ≧100,000/mm
- •AST and ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl. Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.
排除标准
- •Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
- •Patients can not have oral intake
- •Patients receiving Flucytosine treatment
- •Patients with severe pleural effusion or ascites.
- •Patients who have brown brain metastasis
- •Patients with diarrhea 4 or more times per day
- •Patients with active gastrointestinal bleeding.
- •Patients with intestinal obstruction
- •Patients with active infection.
- •Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
- •Patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- •Patients with significant cardiac disease.
- •Patients with active multiple cancer.
- •Patients with neuropathy ≥ grade 2
- •Patients who are pregnant, are of childbearing potential, or breast-feeding.
- •Patients with severe mental disorder.
- •Patients with a history of serious allergic reaction.
- •Judged to be ineligible for this protocol by the investigation.
研究组 & 干预措施
1
mFOLFOX6 （ → IRIS ( Irinotecan and S-1) ）
干预措施: L-Plat (Drug)
1
mFOLFOX6 （ → IRIS ( Irinotecan and S-1) ）
干预措施: Isovorin (Drug)
1
mFOLFOX6 （ → IRIS ( Irinotecan and S-1) ）
干预措施: 5-FU (Drug)
2
IRIS ( Irinotecan and S-1 ) → mFOLFOX6
干预措施: Campto, Topotesin (Drug)
2
IRIS ( Irinotecan and S-1 ) → mFOLFOX6
干预措施: TS-1 (Drug)
结局指标
主要结局
PFS of 1st line treatment
时间窗: 2-years
次要结局
- OS(4-years)
- objective tumor response(1-year)
- PFS of 2nd line treatment(1-year)
- safety(4-years)