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Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2026 → Jun 1, 2027
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 44% 300 → 168 participants
See other at-risk trials from The First Affiliated Hospital with Nanjing Medical University

Record History

  1. Primary endpoint(s) modified Enrollment reduced: 300 → 168 participants · Recruitment opened · Start date changed from estimate of Dec 2019 to Oct 1, 2021 · 9 morev2 Show 12 more changesShow less
    • Enrollment reduced: 300 → 168 participants
    • Recruitment opened
    • Start date changed from estimate of Dec 2019 to Oct 1, 2021
    • Primary completion pushed from Dec 2026 to Jun 1, 2027
    • Completion pushed from Dec 2026 to Jun 1, 2030
    • Trial arms changed: 3 → 2
    • Study sites: 0 to 1
    • Interventions: transanal local excision following radiotherapy (Procedure) to TME (Procedure), transanal local excision following radiotherapy (Procedure)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 5 to 14
    • Study title shortened, about 6 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Trial Details
NCT Number NCT04098471
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Rectal Cancer
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov