Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

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.

Conditions

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

Interventions

OTHER

Total mesorectal excision

Direct surgery without receiving neoadjuvant chemoradiotherapy

OTHER

Neoadjuvant Chemotherapy followed by total mesorectal excision

Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery

Sponsors & Collaborators

• Baskent University

  collaborator OTHER

• Dokuz Eylul University

  collaborator OTHER

• Halic University

  collaborator OTHER

• Acibadem Kent Hospital

  collaborator OTHER

• Istanbul Health and Technology University

  collaborator OTHER

• Turkish Society of Colon and Rectal Surgery

  lead OTHER

Principal Investigators

• Feza Karakayali, Prof. · Baskent University

• Aras Emre Canda, Prof. · Acibadem Kent Hospital

• Ilknur Erenler Bayraktar, Prof. · Halic University

• Onur Bayraktar, Prof. · Memorial Sisli Hospital

• Cigdem N Arslan, Prof. · Istanbul Health and Technology University

• Tayfun Bisgin, Prof. · Dokuz Eylul University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2030-08-01

Completion

2035-08-01

Countries

• Turkey (Türkiye)

Study Locations