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ClinicalTrials.gov ID

NCT06823297

Lead Sponsor

Turkish Society of Colon and Rectal SurgeryOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

436Estimated

Last Update Posted

Jun 27, 2025Actual

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Aug 1, 2030Estimated

Completion Date

Aug 1, 2035Estimated

Official Title

Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study

Brief Summary

This project aims to compare the oncological and functional outcomes of patients with mid-rectal cancer who have a low risk of local recurrence (without MRF involvement) and who either receive or do not receive neoadjuvant chemoradiotherapy (nCRT).

Main Question:

H0: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), there is no difference in 3-year disease-free survival between direct TME and TME after nCRT.

H1: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), direct TME is associated with worse 3-year disease-free survival compared to TME after nCRT.

Participants already taking both interventions as part of their regular medical care for rectal cancer will be recruited in a prospective database for 5 years.

Detailed Description

Neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME) is the standard treatment for patients with locally advanced rectal cancer. This approach has been shown to improve local control and reduce recurrence rates. However, there is no clear evidence showing the advantage of neoadjuvant CRT in high and middle rectal tumors without involvement of mesorectal fascia (MRF). The MERCURY study demonstrated that preoperative MRI-predicted positive CRM is an independent factor for local recurrence. Following this study, the selective use of nCRT in patients at high risk of local recurrence has been proposed.

The ESMO guidelines indicate that T3a/b rectal tumors located above the levator muscles, without involvement of the circumferential resection margin (CRM) or extramural venous invasion (EMVI), are associated with a very low risk of local recurrence. Consequently, they suggest that upfront TME may be an appropriate treatment option for this subgroup of patients. This recommendation remains unchanged in the presence of lymph node involvement within the same group. For clinically staged cT3a/b mid- or high-rectal tumors with clear CRM and no evidence of EMVI, the routine use of nCRT remains a subject of debate. If the surgeon consistently performs high-quality total mesorectal excision (TME), upfront surgery may be a suitable treatment option for this subgroup of patients.

In line with these recommendations, some surgeons perform upfront TME for patients with T2-3 node-positive mid-rectal cancer in the absence of MRF involvement. However, in these cases, the common approach is to administer neoadjuvant chemoradiotherapy. This study seeks to observe whether upfront TME achieves similar 3-year disease-free survival compared to the standard approach of nCRT followed by TME in patients with cT2N+ and cT3Nx mid-rectal cancer without mesorectal fascia involvement.

• Mid-Rectal Cancer
• Rectal Cancer Stage II
• Rectal Cancer Stage III

• Total mesorectal excision
• Neoadjuvant Chemotherapy followed by total mesorectal excision

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Pathologically confirmed rectal cancer
• Rectal cancer within 6-12 cm from anal verge confirmed by sigmoidoscopy or located between the anorectal junction and peritoneal reflection identified by MRI
• Clinical local staging performed by MRI
• cT2N+, cT3N0 and cT3N+ tumors
• Patients without mesorectal fascia involvement assessed by MRI (≤1 mm)
• Patients without pathological (short axis ≥7 mm) lateral (extramesorectal) lymph nodes on MRI
• Patients without EMVI on MRI

Exclusion Criteria:

• cT4 tumors
• Stage IV disease
• Patients with MSI (+) in TME pathology
• PAtients who received neoadjuvant immunotherapy
• Emergency surgery
• Clinical obstruction
• Previous pelvic radiotherapy
• Patients treated without a multidisciplinary council decision
• Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)
• Familial adenomatous polyposis (FAP), attenuated FAP, and other polyposis syndromes
• Hereditary non-polyposis colorectal cancer (Lynch syndrome)
• Synchronous colon tumors

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Turkish Society of Colon and Rectal SurgeryOTHER

Collaborators

Baskent UniversityOTHER

Dokuz Eylul UniversityOTHER

Halic UniversityOTHER

Acibadem Kent HospitalOTHER

Istanbul Health and Technology UniversityOTHER

dronurbayraktar@gmail.com

candaae@gmail.com

tayfun.bisgin@gmail.com