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

Rectal Cancer Clinical Trial

Official title:

Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496270
• Other study ID #: GIHSYSU-28
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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