跳至主要内容
临床试验/NCT00423696
NCT00423696已完成2 期

Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]

UNICANCER15 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2006年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
UNICANCER
入组人数
145
试验地点
15
主要终点
Progression-free survival at 6 months

研究概览

简要总结

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

详细描述

OBJECTIVES:

Primary

  • Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotecan hydrochloride, leucovorin calcium, and fluorouracil (FOLFIRI) vs bevacizumab and irinotecan hydrochloride and capecitabine (XELIRI).

Secondary

  • Compare the toxicities of these regimens in these patients.
  • Compare the objective response rate and duration of response in patients treated with these regimens.
  • Compare the tumor control in patients treated with these regimens.
  • Compare the progression-free and overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

研究设计

研究类型
Interventional
分配方式
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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

bevacizumab + FOLFIRI

Experimental

干预措施: irinotecan hydrochloride (Drug)

bevacizumab + FOLFIRI

Experimental

干预措施: bevacizumab (Biological)

bevacizumab + FOLFIRI

Experimental

干预措施: fluorouracil (Drug)

bevacizumab + FOLFIRI

Experimental

干预措施: leucovorin calcium (Drug)

bevacizumab + XELIRI

Experimental

干预措施: bevacizumab (Biological)

bevacizumab + XELIRI

Experimental

干预措施: capecitabine (Drug)

bevacizumab + XELIRI

Experimental

干预措施: irinotecan hydrochloride (Drug)

结局指标

主要结局

Progression-free survival at 6 months

次要结局

  • Toxicities
  • Duration of objective response and stable disease
  • Progression-free survival
  • Overall survival
  • Percentage of stable disease responses
  • Percentage of objective responses
  • Quality of life

研究者

发起方
UNICANCER
申办方类型
Other
责任方
Sponsor

研究点 (15)

Loading locations...

相似试验

Bevacizumab and Combination Chemotherapy as... | 临床试验