NCT02935764Unknown3 期
Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 164
- 主要终点
- progression free survival
研究概览
简要总结
This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •life expectancy of ≥ 3 months
- •patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
- •at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
- •have adequate bone marrow, hepatic, and renal function
排除标准
- •patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- •patients with symptomatic brain metastases
- •active clinical severe infection
- •previously received irinotecan
- •dihydropyrimidine dehydrogenase (DPD) enzyme adequate
研究组 & 干预措施
FOLFIRI
Experimental
5-fluorouracil,folinate combined with irinotecan
干预措施: Irinotecan (Drug)
FOLFIRI
Experimental
5-fluorouracil,folinate combined with irinotecan
干预措施: 5-fluorouracil (Drug)
FOLFIRI
Experimental
5-fluorouracil,folinate combined with irinotecan
干预措施: Leucovorin (Drug)
IRINOTECAN
Active Comparator
irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
progression free survival
时间窗: 2 months
次要结局
- overall survival(6 months)
- overall response rate(2 months)
- Number of Participants with Adverse Events(2 months)
- quality of life questionnaire(2 months)
研究者
Weijian Guo
Vice Director of Department of Medical Oncology, Clinical Professor
Fudan University
相似试验
已完成
3 期
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00457691Pfizer768
已完成
3 期
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon CancerStage II Colon CancerStage III Colon CancerNCT00004931National Cancer Institute (NCI)2,472
终止
1 期
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal CancerDiarrheaColorectal NeoplasmsNCT00036517PhytoCeutica30
已完成
2 期
Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00952029Federation Francophone de Cancerologie Digestive492
Unknown
2 期
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal CancerColorectal CancerNCT00075595GERCOR - Multidisciplinary Oncology Cooperative Group