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

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: total mesorectal excision

• Registration Number: NCT05496270
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2019-01
• Status Verified: 2022-08
• Study Completion: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1509

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nCRT+TME	total mesorectal excision	patients underwent TME following neoadjuvant treatment
TME	total mesorectal excision	patients only underwent TME

Primary Outcome Measures

Name	Time	Method
3-year diseases free survival	3 years after surgery

Secondary Outcome Measures

Name	Time	Method
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
Margin-free （R0）resection rate	Immediately after the surgery