NCT04098471

Brief Summary

A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision，transanal local excision following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Dec 2019

Longer than P75 for not_applicable

Status
not yet recruiting

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 Progress93%
Dec 2019Dec 2026

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

7 years

First QC Date

September 19, 2019

Last Update Submit

September 20, 2019

Conditions

Rectal Cancer

Keywords

transanal local excisionT2N0M0

Outcome Measures

Primary Outcomes (1)

  • 5-years disease free survival rate

    5 years

Secondary Outcomes (5)

  • 5-years overall survival rate

    5 years

  • local recurrance rate

    5 years

  • operative time

    1 day

  • hospitalization time

    15 days

  • postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire

    5 years

Study Arms (3)

single transanal loca excision

EXPERIMENTAL
Procedure: transanal local excision following radiotherapy

transanal local excision following radiotherapy

EXPERIMENTAL
Procedure: transanal local excision following radiotherapy

total mesorectal excision

EXPERIMENTAL
Procedure: transanal local excision following radiotherapy

Interventions

transanal local excision following radiotherapyPROCEDURE

transanal local excision following radiotherapy

single transanal loca excisiontotal mesorectal excisiontransanal local excision following radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperative pathology confirmed adenocarcinoma.
  • Preoperative MRI or digital examination of tectum confirmed that the distances from the lower edge of the tumors to the anus were less than 5 cm.
  • The mass is not fixed.
  • Preoperative MRI and rectal EUS indicated that the tumor only invaded muscular layer (T2).
  • No suspicious lymphatic metastasis or distant metastasis was found on preoperative high-resolution CT and MRI.
  • American Society of Anesthesiologists(ASA) grade I-III.
  • Informed consent.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

You may not qualify if:

  • Age\<18, or\>75.
  • Have other cancer history.
  • The pathology of rectal tumors is non-adenocarcinoma.
  • Multiple primary colorectal tumors.
  • Preoperative CT and MR showed that lymphatic metastasis and distant metastasis could be positive.
  • Pregnant or lactating women.
  • Patients with severe mental disorders.
  • ASA score \> 3.
  • Receive other cancer treatments (radiotherapy, chemotherapy).
  • Complication with other intestinal diseases (FAP, HNPCC, active ulcerative colitis or Crohn's disease).
  • The general situation is poor and there are other uncontrollable diseases.
  • Preoperative tumor stage was not T2N0M0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tang J, Zhang Y, Zhang D, Zhang C, Jin K, Ji D, Peng W, Feng Y, Sun Y. Total Mesorectal Excision vs. Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: A Multicenter Randomized Trial. Front Surg. 2022 Feb 1;9:812343. doi: 10.3389/fsurg.2022.812343. eCollection 2022.

    PMID: 35178428DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yueming Sun, PhD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Yueming Sun, PhD

CONTACT

02568306026jssym@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

December 1, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share