A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 8
- 主要终点
- Time To Progression
研究概览
简要总结
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.
详细描述
There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastatic colorectal cancer
- •Measurable or evaluable disease
- •ECOG performance status ≤ 2
- •Age 18 - 72 years
- •Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
- •Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
- •Patients must be able to understand the nature of this study
- •Written informed consent
排除标准
- •Previous 1st line chemotherapy
- •Adjuvant chemotherapy with Irinotecan regimen with relapse < 6 months after the completion
- •Active infection
- •History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
- •Patients with unstable CNS metastases
- •Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
- •Patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
研究组 & 干预措施
1
FOLFIRI/Avastin
干预措施: 5-Fluorouracil (Drug)
1
FOLFIRI/Avastin
干预措施: Irinotecan (Drug)
1
FOLFIRI/Avastin
干预措施: Leucovorin (Drug)
1
FOLFIRI/Avastin
干预措施: Bevacizumab (Drug)
2
XELIRI/Avastin
干预措施: Capecitabine (Drug)
2
XELIRI/Avastin
干预措施: Bevacizumab (Drug)
2
XELIRI/Avastin
干预措施: Irinotecan (Drug)
结局指标
主要结局
Time To Progression
时间窗: 1 year
次要结局
- Symptoms improvement(Assessment every two cycles)
- Quality of life(Assessment every two cycles)
- Objective Response Rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Overall Survival(Probability of 1-year survival (%))
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)