Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer
Completed
- Conditions
- Rectal Cancer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1509
Inclusion Criteria
- 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)
Exclusion Criteria
- emergency surgery due to bleeding, perforation, and bowel obstruction,
- recurrent rectal cancer,
- inflammatory bowel disease,
- Stage IV.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year diseases free survival 3 years after surgery
- Secondary Outcome Measures
Name Time Method Local recurrence rate 3 years after the surgery 3-year overall survival rate 3 years after surgery Number of participants with surgical complications 30 days after surgery Margin-free （R0）resection rate Immediately after the surgery