Evaluation of Bevacizumab Combined With First Line Chemotherapy in Patients Aged 75 and Over Suffering From Metastatic Colorectal Adenocarcinoma. Phase II Randomized - Intergroup Trial: FFCD, FNCLCC, GERICO
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not related to chemotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer.
PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate composite efficacy and safety, in terms of objective response or tumoral stability by RECIST criteria and no deterioration in the Spitzer QoL Index score of ≥ 2 points at 4 months, in older patients with unresectable metastatic colorectal adenocarcinoma treated with bevacizumab and first-line chemotherapy.
- To evaluate tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not linked to chemotherapy, in these patients.
Secondary
- To evaluate toxicity in these patients.
- To assess time to deterioration of autonomy in these patients.
- To assess survival with no deterioration of autonomy of these patients.
- To evaluate time to deterioration of quality of life of these patients.
- To evaluate percentage of patients who received at least 2/3 of the protocol treatment at month 4.
- To assess time to treatment failure in these patients.
- To assess progression-free survival and global survival of these patients.
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
- 75 Years 至 120 Years（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
Chemotherapy associated with bevacizumab
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab
干预措施: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab (Drug)
Chemotherapy
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)
干预措施: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) (Drug)
结局指标
主要结局
Tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not related to chemotherapy
时间窗: 4 months
Deterioration in the Spitzer QoL Index score of ≥ 2 points at baseline and at 4 months
时间窗: 4 months
Efficacy, in terms of objective response or tumoral stability by RECIST criteria
时间窗: 4 months
次要结局
- Survival with no deterioration of autonomy(4 months)
- Toxicity(4 months)
- Time to deterioration of autonomy(4 months)