Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Phase 2

Recruiting

• Conditions: Advanced Rectal Cancer
• Interventions: Drug: XELOX; Drug: Capecitabine monotherapy; Radiation: Radiation

• Registration Number: NCT05228431
• Lead Sponsor: Zhen-Hai Lu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-22
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Study Start: 2022-03-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sandwich Regimen	XELOX	All rectal patients in this group will receive standard surgical resection.
Sandwich Regimen	Capecitabine monotherapy	All rectal patients in this group will receive standard surgical resection.
Sandwich Regimen	Radiation	All rectal patients in this group will receive standard surgical resection.

Primary Outcome Measures

Name	Time	Method
Rate of pCR	One week after surgery	rate of pathological complete remission

Secondary Outcome Measures

Name	Time	Method
OS	5 years	overall survival
DFS	3 years	Disease free survival

Trial Locations

Locations (1)

Zhenhai Lu; 🇨🇳 Guangzhou, Guangdong, China