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RECRUITING
NCT05563922
PHASE2

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Official title: Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2022-09-01

Completion Date

2027-08-31

Last Updated

2022-10-03

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Total Neoadjuvant Chemoradiotherapy

Radiotherapy:45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week CapOx: Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection

Locations (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China