Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R)

Overview of the CINTS-R Trial

Background

Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment for locally advanced rectal cancer (LARC). New methods like total neoadjuvant therapy (TNT) and immunotherapy are promising. We need better ways to select patients for these treatments. Our previous research shows that circulating tumour DNA (ctDNA) can help predict treatment outcomes and guide therapy choices.

Trial Design

The CINTS-R trial is a large study to compare ctDNA-guided treatment with standard therapy for LARC patients. We will include 470 patients with specific cancer stages from seven centers in China. Patients will be randomly assigned to either the experimental group or the control group.

  • Experimental Group: Will receive tailored neoadjuvant treatments based on ctDNA analysis.
  • Control Group: Will receive standard modified nCRT.

The main goal is to measure the treatment failure rate after two years. We will also look at recurrence times, overall survival, disease-free survival, and quality of life.

Ethics and Sharing Results

This study has received ethical approval and will securely store all data. We will share our findings through academic publications and conferences.

Trial Registration

The trial is registered on ClinicalTrials.gov with ID NCT05601505.

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