Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Progress Free Survival
研究概览
简要总结
Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-80
- •ECOG score: 0 or 1
- •Histological confirmed of Colorectal Adenocarcinoma
- •History of exposure to oxaliplatin
- •With local recurrent or metastatic focus
- •Tumor resectable confirmed by at less 3 hepatobiliary surgeon
- •Informed content acquired
排除标准
- •History of Exposure to Irinotecan
- •Received surgery in recently 4 weeks or did not recover from surgery
- •Other history of cancer in recent 5 years
- •Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
- •Women with potential pregnancy.
研究组 & 干预措施
Adjuvant therapy arm
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
干预措施: 5-fluorouracil (Drug)
Neoadjuvant therapy arm
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
干预措施: Irinotecan (Drug)
Neoadjuvant therapy arm
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
干预措施: 5-fluorouracil (Drug)
Neoadjuvant therapy arm
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
干预措施: Local radiotherapy (Radiation)
Neoadjuvant therapy arm
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
干预措施: R0 resection (Procedure)
Adjuvant therapy arm
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
干预措施: Irinotecan (Drug)
Adjuvant therapy arm
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
干预措施: Local radiotherapy (Radiation)
Adjuvant therapy arm
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
干预措施: R0 resection (Procedure)
结局指标
主要结局
Progress Free Survival
时间窗: 3 years
次要结局
- Overall Survival(3 Years)
- R0 Resection Rate(6 Month)
- Treatment RelatedToxicity(3 Year)
- Life Quality(3 Years)
研究者
Ping Lan
Professor
Sixth Affiliated Hospital, Sun Yat-sen University