Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 19
- 主要终点
- Progression Free Survival (PFS) rate
研究概览
简要总结
Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria.
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 —（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
Capecitabine + temozolomide + Bevacizumab
干预措施: Capecitabine (Drug)
Capecitabine + temozolomide + Bevacizumab
干预措施: Temozolomide (Drug)
LV5FU2 + streptozotocin
干预措施: LV5FU2 (Drug)
LV5FU2 + streptozotocin
干预措施: Streptozocin (Drug)
Capecitabine + temozolomide
干预措施: Capecitabine (Drug)
Capecitabine + temozolomide
干预措施: Temozolomide (Drug)
LV5FU2 + streptozotocin + Bevacizumab
干预措施: LV5FU2 (Drug)
LV5FU2 + streptozotocin + Bevacizumab
干预措施: Streptozocin (Drug)
LV5FU2 + streptozotocin + Bevacizumab
干预措施: Bevacizumab (Drug)
Capecitabine + temozolomide + Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) rate
时间窗: Until disease progression or unacceptable toxicity (median 24 months)
次要结局
- Toxicity (NCI-CTCAE 4.0)(Until disease progression or unacceptable toxicity)