NCT03548844

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 7, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

May 25, 2018

Last Update Submit

May 25, 2018

Conditions

Rectal CancerSurgery

Outcome Measures

Primary Outcomes (1)

  • DFS

    Disease-free survival

    3 years

Secondary Outcomes (5)

  • OS

    3 years

  • Morbidity rate

    1 year

  • Mortality rate

    1 year

  • Anorectal function outcomes

    3 years

  • Quality of life

    3 years

Study Arms (2)

local excision group

EXPERIMENTAL

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

Procedure: local excision

total mesorectal excision group

ACTIVE COMPARATOR

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

Procedure: total mesorectal excision

Interventions

local excisionPROCEDURE

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

local excision group
total mesorectal excisionPROCEDURE

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

total mesorectal excision group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 、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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Liang Kang, MD,PhD

    The Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Kang, MD,PhD

CONTACT

008613602886833eonkang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This trial is a a two-arm, open labelled, prospective, randomized phase III studies. Eligible patients with ypT0-1cN0 rectal cancer patients will be randomly assigned, in a 1:1 ratio, to receive either observation (local excision group) or complementary rectal excision (total mesorectal excision group).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 7, 2018

Study Start

May 24, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2023

Last Updated

June 7, 2018

Record last verified: 2018-05

Locations

CN(1)