Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 4
- 主要终点
- Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin.
- Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens.
Secondary
- Compare the failure-free and overall survival of patients treated with these regimens.
- Compare the toxic effects and adverse events associated with these regimens in these patients.
- Compare the limited health assessments of patients treated with these regimens.
- Compare the health economics associated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MdG (modified de Gramont)
2 weekly 5FU/FA schedule
干预措施: FOLFOX regimen (Drug)
MdG (modified de Gramont)
2 weekly 5FU/FA schedule
干预措施: fluorouracil (Drug)
MdG (modified de Gramont)
2 weekly 5FU/FA schedule
干预措施: leucovorin calcium (Drug)
MdG (modified de Gramont)
2 weekly 5FU/FA schedule
干预措施: quality-of-life assessment (Procedure)
OxMdG (80%) for 12 weeks
MdG + oxaliplatin
干预措施: FOLFOX regimen (Drug)
OxMdG (80%) for 12 weeks
MdG + oxaliplatin
干预措施: fluorouracil (Drug)
OxMdG (80%) for 12 weeks
MdG + oxaliplatin
干预措施: leucovorin calcium (Drug)
OxMdG (80%) for 12 weeks
MdG + oxaliplatin
干预措施: oxaliplatin (Drug)
OxMdG (80%) for 12 weeks
MdG + oxaliplatin
干预措施: quality-of-life assessment (Procedure)
Capcitabine
干预措施: capecitabine (Drug)
Capcitabine
干预措施: quality-of-life assessment (Procedure)
OxCap
干预措施: capecitabine (Drug)
OxCap
干预措施: oxaliplatin (Drug)
OxCap
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
时间窗: PFS
Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
时间窗: Baseline and 14 weeks
Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks
次要结局
- Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks(Baseline, 14 and 24 weeks)
- Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap(post 24 weeks)
- Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap(post 24 weeks)
- Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap(Baseline, 14 and 24 weeks)
- Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap(Baseline, 14 and 24 weeks)
- Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks(Baseline and 24 weeks)
- Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap(post 24 weeks)
- Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap(post 24 weeks)
- Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap(post 24 weeks)
- Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap(Baseline, 14 and 24 weeks)
研究者
Cheryl Pugh
Clinical Project manager for FOCUS2 for Sponsor
Medical Research Council