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临床试验/NCT05228431
NCT05228431招募中2 期

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

Zhen-Hai Lu1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2022年3月2日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

All rectal patients in this group will receive standard surgical resection.

干预措施: XELOX (Drug)

Sandwich Regimen

Experimental

All rectal patients in this group will receive standard surgical resection.

干预措施: Capecitabine monotherapy (Drug)

Sandwich Regimen

Experimental

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

发起方
Zhen-Hai Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhen-Hai Lu

Pofessor

Sun Yat-sen University

研究点 (1)

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