Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinom
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
| Condition(s) | Rectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Zhongshan Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2022-09-01 |
| NCT ID | NCT05563922 |
| Official listing | https://clinicaltrials.gov/study/NCT05563922 |