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Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT05496270
Collaborator
(none)
1,509
Enrollment
103
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: total mesorectal excision

Study Design

Study Type:
Observational
Actual Enrollment :
1509 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
TME

patients only underwent TME

Procedure: total mesorectal excision
Other Names:
  • neoadjuvant treatment

    		•
    nCRT+TME

    patients underwent TME following neoadjuvant treatment

    Procedure: total mesorectal excision
    Other Names:
  • neoadjuvant treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3-year diseases free survival [3 years after surgery]

    Secondary Outcome Measures

    1. Margin-free （R0）resection rate [Immediately after the surgery]

    2. 3-year overall survival rate [3 years after surgery]

    3. Number of participants with surgical complications [30 days after surgery]

    4. Local recurrence rate [3 years after the surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Eighteen- to eighty-year-old patients.

    2. T3 rectal cancer with clear mesorectal fascia (MRF),

    3. within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)

    Exclusion Criteria:

    1. emergency surgery due to bleeding, perforation, and bowel obstruction,

    2. recurrent rectal cancer,

    3. inflammatory bowel disease,

    4. Stage IV.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanhong Deng, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05496270
    Other Study ID Numbers:
    • GIHSYSU-28
    First Posted:
    Aug 11, 2022
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Aug 11, 2022