The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pathological response rate
研究概览
简要总结
The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed adenocarcinoma
- •clinical stage T3-4 and/or N+
- •the distance from anal verge less than 12 cm
- •without distance metastases
- •performance status score: 0~1
- •UGT1A1*28 6/6 or 6/7
- •without previous anti-cancer therapy
- •sign the inform consent
排除标准
- •pregnancy or breast-feeding women
- •serious medical illness
- •baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- •DPD deficiency
- •UGT1A1*28 7/7
研究组 & 干预措施
CRT group
Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check
干预措施: Blood concentration check (Diagnostic Test)
结局指标
主要结局
pathological response rate
时间窗: Surgery scheduled 6-8 weeks after the end of chemoradiation
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
时间窗: During the chemoradiation weekly，assessed up to 5 weeks
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
次要结局
未报告次要终点