XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
研究概览
简要总结
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive factors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Histological proven adenocarcinoma of the colon or rectum
- •Measurable or non-measurable disease
- •Performance status 0-2
- •Adequate renal and hepatic functions
- •Adjuvant chemotherapy must have ended 180 days before inclusion
- •Written informed consent prior to randomization
排除标准
- •Prior treatment with Eloxatin or Xeloda
- •Peripheral neuropathy
- •Evidence of CNS metastasis
- •Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
- •Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
- •Administration of any other experimental drug under investigation within 2 weeks before randomisation
- •Pregnant or breast feeding women
- •Fertile patients must use adequate contraceptives
研究组 & 干预措施
A
Standard XELOX
干预措施: Oxaliplatin (Eloxatin) (Drug)
A
Standard XELOX
干预措施: Capecitabine (Xeloda) (Drug)
B
Chronomodulated XELOX
干预措施: Oxaliplatin (Eloxatin) (Drug)
B
Chronomodulated XELOX
干预措施: Capecitabine (Xeloda) (Drug)
结局指标
主要结局
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
次要结局
- Haematology: before treatment (each 3 weeks)
- Physical examination: before treatment (each 3 weeks)
- Tumor biology: after 1st treatment, every 9th weeks herafter
- Performance status: before treatment (each 3 weeks)
- Biochemistry: after every 3rd treatment (each 9th weeks)
- Tumor assesment: after every 3rd treatment (each 9th weeks)
研究者
Per Pfeiffer
Professor, M.D.
Odense University Hospital