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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhenhai Lu
RECRUITING
Guangzhou
Contact Information
Primary
Zhenhai Lu, Prof
luzhh@sysucc.org.cn
+862087343584
Backup
Jianhong Peng, M.D
pengjh@sysucc.org.cn
+862087343584
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 121
Treatments
Experimental: Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
Related Therapeutic Areas
Sponsors
Leads: Zhen-Hai Lu

This content was sourced from clinicaltrials.gov