A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer
详细描述
In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically confirmed locally advanced rectal cancer;
- •18-70 years ；
- •Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
- •Tumor from anus >5cm and ≤15cm;
- •Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
- •Informed consent;
- •UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6;
排除标准
- •Clinical stage T4b or unresectable disease;
- •History of pelvic radiotherapy;
- •History of chemotherapy within 5 years;
- •History of chronic diarrhea;
- •Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
- •Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
- •UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6;
- •Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
- •Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
- •Mental illness;Pregnant or lactating women;
研究组 & 干预措施
FOLFOXIRI
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
pCR
时间窗: 1 year
Pathological complete response according to Mandard tumor regression grading
次要结局
- locoregional recurrence rate(1 year)
- R0 resection rate(1 year)
- Safety(1 year)
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences