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Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- Or Low-Rectal Cancer After Neoadjuvant Therapy

NCT03548844 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2018-06-07

No results posted yet for this study

Summary

Patients with cT2-4aN0-2M0 mid- or low-rectal cancer received neoadjuvant chemotherapy or combined chemoradiotherapy. Good responders (cT0-1N0) patients received local excision 4-8 weeks after treatment. Pathologically verified ypT0-1 patients are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The composite end points include 3 year disease-free survival (DFS), overall survival (OS), recurrence, major morbidity and quality of life.

Conditions

Interventions

PROCEDURE

local excision

Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .

PROCEDURE

total mesorectal excision

Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to complementary rectal excision (total mesorectal excision group).

Sponsors & Collaborators

  • Yanhong Deng

    lead OTHER

Principal Investigators

  • Liang Kang, MD,PhD · The Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2021-05-31
Completion
2023-05-31

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 NCT03548844 on ClinicalTrials.gov