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

Sun Yat-sen University

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: total mesorectal excision

Study type: Observational

Funder types: Other

Identifiers

NCT05496270

GIHSYSU-28

Details and patient eligibility

About

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.

Enrollment: 1,509 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,509 participants in 2 patient groups

TME

Description:

patients only underwent TME

Treatment:

Procedure: total mesorectal excision

nCRT+TME

Description:

patients underwent TME following neoadjuvant treatment

Treatment:

Procedure: total mesorectal excision