drugset / Trial / NCT05563922

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

NCT05563922 ↗

Phase 2 Recruiting 56 enrolled Shanghai Zhongshan Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.

Timeline

Start
2022-09-01
Primary completion
2025-08-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Other

Indications