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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05496270
Other study ID # GIHSYSU-28
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date August 2022

Study information

Verified date August 2022
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1509
Est. completion date August 2022
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
total mesorectal excision


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary 3-year diseases free survival 3 years after surgery
Secondary Margin-free (R0)resection rate Immediately after the surgery
Secondary 3-year overall survival rate 3 years after surgery
Secondary Number of participants with surgical complications 30 days after surgery
Secondary Local recurrence rate 3 years after the surgery
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