An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Progression-free survival
研究概览
简要总结
This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age;
- •metastatic colorectal cancer scheduled for standard first line chemotherapy;
- •at least 1 measurable lesion;
- •ECOG performance score of 0 or 1.
排除标准
- •prior chemotherapy for metastatic colorectal cancer;
- •prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
- •concomitant malignancies other CRC;
- •history or evidence of CNS disease unrelated to cancer.
研究组 & 干预措施
1
干预措施: 5-FU (Drug)
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: irinotecan (Drug)
1
干预措施: leucovorin (Drug)
1
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: assessed every 8 weeks up to week 102, 3-monthly during follow-up
次要结局
- Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.(Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks)
- Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.(assessed every 4 weeks up to week 102 and at the end of follow-up period)