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

May 25, 2018 updated by: Yanhong Deng

A Prospective Randomized Controlled Trial Of Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- or Low-Rectal Cancer After Neoadjuvant Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Total mesorectal excision is still the standard surgical treatment of mid-and low advanced rectal cancer after neoadjuvant treatment. This radical procedure inevitably has the risk of major short and long term morbidity and anorectal function impairment. Additionally, abdominal perineal resection(APR) with permanent stoma is still applied to some low rectal cancer patients, even though major response had been achieved after neoadjuvant treatment. Previous studies have proposed "wait and see" strategy in clinical complete response patients. The local recurrence rate is still high due to residue adenocarcinoma lesion.

Local excision is a conservative alternative approach associated with low mortality and morbidity and high quality of life. In this study, the investigators proposed local excision in good responders (cT0-1N0) 4-8 weeks after neoadjuvant treatment. Patients with pathologically verified complete response (ypT0-1cN0) are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The purpose of this prospective randomized controlled study is to compare local excision versus total mesorectal excision in pathological complete response (ypT0-1cN0) mid- or low-rectal cancer after neoadjuvant therapy.

Study Type

Interventional

Enrollment (Anticipated)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1、Willing and able to provide written informed consent. 2、Histological or cytological documentation of adenocarcinoma of the rectum (≤8 cm from the anal verge).

    3、ypT0-1cN0 after neoadjuvant therapy 4、No metastatic disease. 5、Patient is at least 18 years of age. 6、Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7、Non complicated primary tumor (obstruction, perforation, bleeding).

Exclusion Criteria:

  • 1、T1, T4 tumour or anal sphincter invasion 2、Metastatic disease (M1) 3、Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy 4、Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study 5、History of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: local excision group
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group)
Procedure: local excision
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .
ACTIVE_COMPARATOR: total mesorectal excision group
Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to complementary rectal excision (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 3 years
Disease-free survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 years
Overall survival
3 years
Quality of life
Time Frame: 3 years
To evaluate quality of life with EORTC QLQ-30 questionnaire
3 years
Anorectal function outcomes
Time Frame: 3 years
To evaluate defecating function with Wexner score
3 years
Morbidity rate
Time Frame: 1 year
Morbidity rate
1 year
Mortality rate
Time Frame: 1 year
Mortality rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanhong Deng

Investigators

  • Principal Investigator: Liang Kang, MD,PhD, The Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 24, 2018

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (ACTUAL)

June 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRSSYSU01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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