Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer
详细描述
By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Preoperative neoadjuvant CT
Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: TME (Procedure)
Preoperative neoadjuvant CT
Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: neoadjuvant CT (Drug)
Preoperative neoadjuvant CT
Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: adjuvant CT (Drug)
Preoperative neoadjuvant CT-RCT
Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: TME (Procedure)
Preoperative neoadjuvant CT-RCT
Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: Concurrent chemo-radiotherapy (Radiation)
Preoperative neoadjuvant CT-RCT
Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: neoadjuvant CT (Drug)
Preoperative neoadjuvant CT-RCT
Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: adjuvant CT (Drug)
Concurrent chemo-radiotherapy
Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: TME (Procedure)
Concurrent chemo-radiotherapy
Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: Concurrent chemo-radiotherapy (Radiation)
Concurrent chemo-radiotherapy
Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
干预措施: adjuvant CT (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: 3 years
the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
次要结局
- Surgery related mortality and complication(3 years)
- Tolerance after neoadjuvant treatment(3 years)
- Predictor efficacy of neoadjuvant chemotherapy for DFS(3 years)
- Resection rate of R0(3 years)
- Pathologic complete remission (pCR) rate(3 years)
研究者
Binbin Cui
Director of colorectal surgery
Harbin Medical University