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Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

NCT05563922 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-10-03

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jian Wang, M.D. · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563922 on ClinicalTrials.gov