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
- the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
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
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
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.
次要结局
未报告次要终点