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Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Recruiting
18 - 75 years of age
Both
Phase 2

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Overview

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

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
        Cachexy

Study details

Advanced Rectal Cancer

NCT05228431

Zhen-Hai Lu

2 May 2024

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