NCT00220116已完成2 期
A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Objective response rates
研究概览
简要总结
To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the 1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the neo-adjuvant and adjuvant setting of resectable metastases.
Primary Endpoint: Objective response rates
Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected) Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause mortality Number undergoing liver resections/curative resection (Ro) rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups
- •No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
- •Unidimensional measurable disease as assessed by CT. (Unless adjuvant therapy only)
- •Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
- •Adequate liver function: Serum Bilirubin <1.5 x upper limit of institutional normal
- •Adequate renal function, calculated Creatinine Clearance >50mls/min
- •No concurrent uncontrolled medical conditions
- •WHO performance status 0,1 or 2
- •Adequate contraceptive precautions, if appropriate
- •Informed written consent
- •Negative pregnancy test in women of child bearing age
- •Life expectancy > 3 months
排除标准
- •Medical or psychiatric condition that comprise the patient's ability to take informed consent.
- •Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months.
- •Patients with any significant symptoms or history of peripheral neuropathy.
结局指标
主要结局
Objective response rates
次要结局
- Treatment related toxicity
- Progression free survival (If not resected)
- Disease free Survival (From metastastectomy, if resected)
- Overall Survival
- 60 Day all cause mortality
- Number undergoing liver resections/curative resection (Ro) rate
研究者
研究点 (2)
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