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Clinical Trials/NCT05228431
NCT05228431
Recruiting
Phase 2

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 site in 1 country121 target enrollmentMarch 2, 2022

Overview

Phase
Phase 2
Intervention
XELOX
Conditions
Advanced Rectal Cancer
Sponsor
Zhen-Hai Lu
Enrollment
121
Locations
1
Primary Endpoint
Rate of pCR
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2, 2022
End Date
May 1, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Zhen-Hai Lu
Responsible Party
Sponsor Investigator
Principal Investigator

Zhen-Hai Lu

Pofessor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Multiple primary tumor

Arms & Interventions

Sandwich Regimen

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

Intervention: XELOX

Sandwich Regimen

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

Intervention: Capecitabine monotherapy

Sandwich Regimen

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

Intervention: Radiation

Outcomes

Primary Outcomes

Rate of pCR

Time Frame: One week after surgery

rate of pathological complete remission

Secondary Outcomes

  • OS(5 years)
  • DFS(3 years)

Study Sites (1)

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