Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- • Pathological complete remission rate (pCR)
研究概览
简要总结
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- •the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
排除标准
- •metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status > 3
- •patients not deemed fit for radiotherapy, capecitabine or surgery
- •pregnant or lactating patients
- •women with child bearing potential who lack effective contraception
- •patients below 18 years old
研究组 & 干预措施
conventional fraction
Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
干预措施: conventional fraction (Radiation)
SIB
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
干预措施: SIB (Radiation)
结局指标
主要结局
• Pathological complete remission rate (pCR)
时间窗: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
次要结局
- Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)(during preoperative treatment and after surgery for 5 years)
研究者
Hua Ren
Attending physician
Chinese Academy of Medical Sciences