Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Rate of pCR
研究概览
简要总结
In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.
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 rectal adenocarcinoma.
- •Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.
- •No metastasis
- •No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.
- •Age ranged from 18 to 75
- •No previous radiotherapy,surgery and chemotherapy.
排除标准
- •Multiple primary tumor
研究组 & 干预措施
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
干预措施: XELOX (Drug)
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
干预措施: Capecitabine monotherapy (Drug)
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
干预措施: Radiation (Radiation)
结局指标
主要结局
Rate of pCR
时间窗: One week after surgery
rate of pathological complete remission
次要结局
- OS(5 years)
- DFS(3 years)
研究者
Zhen-Hai Lu
Pofessor
Sun Yat-sen University
