NCT00209703终止2 期
Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse event
研究概览
简要总结
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
详细描述
A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of colorectral adenocarcinoma.
- •Measurable or assessable lesions.
- •Age: 15 ~ 75 years.
- •Performance Status (ECOG): 0 ~
- •Prior chemotherapy within 2 regimens.
- •Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm
- •Hb 10.0 g/dl. Platelet count 100,000/mm
- •GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- •(10) Predicted survival for >8 weeks. (11) Able to give written informed consent.
排除标准
- •Severe pleural effusion or ascites.
- •Metastasis to the central nervous system (CNS).
- •Active gastrointestinal bleeding.
- •Active infection.
- •Uncontrolled ischemic heart disease.
- •Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- •Active multiple cancer.
- •Severe mental disorder.
- •Pregnancy, possible pregnancy, or breast-feeding.
- •Patients with neuropathy ≥ grade 2
- •Judged to be ineligible for this protocol by the attending physician.
结局指标
主要结局
Incidence and severity of adverse event
次要结局
- Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
研究者
研究点 (2)
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