Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05228431

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Led by Zhen-Hai Lu · Updated on 2024-04-22

121

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed rectal adenocarcinoma
  • Clinical stage T3-4 or any T with N1 lymph node involvement
  • No distant metastasis
  • No signs of intestinal obstruction, or obstruction relieved after proximal colostomy
  • Age between 18 and 75 years
  • No prior radiotherapy, surgery, or chemotherapy for rectal cancer
Not Eligible

You will not qualify if you...

  • Multiple primary tumors
  • Cachexia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhenhai Lu

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

Z

Zhenhai Lu, Prof

CONTACT

J

Jianhong Peng, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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