NCT05496270

Brief Summary

Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

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

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

5 years

First QC Date

August 9, 2022

Last Update Submit

August 9, 2022

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year diseases free survival

    3 years after surgery

Secondary Outcomes (4)

  • Margin-free （R0）resection rate

    Immediately after the surgery

  • 3-year overall survival rate

    3 years after surgery

  • Number of participants with surgical complications

    30 days after surgery

  • Local recurrence rate

    3 years after the surgery

Study Arms (2)

TME

patients only underwent TME

Procedure: total mesorectal excision

nCRT+TME

patients underwent TME following neoadjuvant treatment

Procedure: total mesorectal excision

Interventions

total mesorectal excisionPROCEDURE
Also known as: neoadjuvant treatment
TMEnCRT+TME

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

T3 mid-low rectal cancer patients with clear MRF

You may qualify if:

  • Eighteen- to eighty-year-old patients.
  • T3 rectal cancer with clear mesorectal fascia (MRF),
  • within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)

You may not qualify if:

  • emergency surgery due to bleeding, perforation, and bowel obstruction,
  • recurrent rectal cancer,
  • inflammatory bowel disease,
  • Stage IV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

August 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08