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NOT YET RECRUITING
NCT06823297

Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

Sponsor: Turkish Society of Colon and Rectal Surgery

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

436

Start Date

2025-08-01

Completion Date

2035-08-01

Last Updated

2025-06-27

Healthy Volunteers

No

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

Locations (5)

Baskent University

Ankara, Turkey (Türkiye)

Istanbul Health and Technology University

Istanbul, Turkey (Türkiye)

Memorial sisli Hospital

Istanbul, Turkey (Türkiye)

Acibadem Kent Hospital

Izmir, Turkey (Türkiye)

Dokuz Eylul University

Izmir, Turkey (Türkiye)