Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Radical Surgery ( CME + D3 ) for Advanced Colon Cancer : Prospective, a Single-arm, Single Central, Clinical Trial Research
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Investigate patients ORR
研究概览
简要总结
In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.
详细描述
This is prospective,a single-arm, single center, clinical trail study.The patient entered the study after meeting that criteria.The ORR, R0 resection, OS and DFS of patients and neoplasm down-staging status,etc would be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Diagnosis of colon neoplasm
- •18 years to 70 years
- •Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2
- •ECOGS score≤2
- •thoraco-abdomina CT showed no obvious metastasis（The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT) cT4,cN0-2,M0 radiography Inclusion Criteria（according postoperative enhanced CT or MRI）
- •progress tubercle penetrate peritoneotome base
- •progress tubercle penetrate serous surface of neighboring organ
- •progress tubercle development by late mesentery or side abdominis
排除标准
- •Appeared other system cancer
- •Patient with postoperative recurrent of colon cancer
- •Patient with malignancies history in recent 5 years
- •Pregnant or female of suckle period
- •The patient have adjuvant radiotherapy record in other system cancer before this time treatment，and Patient with surgical contraindications.
- •The patient have accepted adjuvant chemoradiotherapy before this time treatment.
- •Distant metastasis found during surgery
- •Patients with poor radiotherapy compliance and difficulty in coordination
- •Patients with mental disorders
结局指标
主要结局
Investigate patients ORR
时间窗: 7 days after surgery
Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)
次要结局
- neoplasm down-staging status(one month after surgery)
- R0 resection(immediately after surgery)
- Quality of life score(one month after surgery)
- Investigate operation safety score(one month after surgery)
- local recurrent rate of neoplasm(2 years after surgery)
- Investigate patience pRR (pathologic response rate)(7 days after surgery)