← Back to Clinical Trials
Recruiting Phase 2 NCT05563922

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

Trial Parameters

Condition Rectal Cancer
Sponsor Shanghai Zhongshan Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 56
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-09-01
Completion 2025-08-31
Interventions
Total Neoadjuvant Chemoradiotherapy

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Age≥18 years * cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy * Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge * Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment, meanwhile is suitable for the implementation of organ preservation strategy after discussion within the multidisciplinary team of the hospital * No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment * No contraindications to chemoradiotherapy * No other colorectal organic diseases * Voluntarily sign the informed consent Exclusion Criteria: * Have received previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment * Patients with concurrent colorectal organic diseases * Patients with familial polyposis * Patients with a pr

Related Trials