Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05228431
Study type Interventional
Source Sun Yat-sen University
Contact Zhenhai Lu, Prof
Phone +862087343584
Email luzhh@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date March 2, 2022
Completion date May 1, 2028

See also
  Status Clinical Trial Phase
Completed NCT03156036 - Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC Phase 2
Active, not recruiting NCT03781323 - Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer Phase 2
Active, not recruiting NCT02031939 - Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Phase 3
Not yet recruiting NCT05359393 - A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis Phase 2
Not yet recruiting NCT05359406 - A Combination Therapy Including Anti-PD-1 Immunotherapy in Rectal Cancer With Refractory Distal Metastasis Phase 2
Suspended NCT01872104 - Safety and Efficiency of Photodynamic Therapy for Rectal Cancer Phase 2/Phase 3