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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05496270
Enrollment
1509
Registered
2022-08-11
Start date
2014-01-31
Completion date
2022-08-31
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

PROCEDUREtotal mesorectal excision

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frame
3-year diseases free survival3 years after surgery

Secondary

MeasureTime frame
Margin-free (R0)resection rateImmediately after the surgery
3-year overall survival rate3 years after surgery
Number of participants with surgical complications30 days after surgery
Local recurrence rate3 years after the surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026