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Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer
Sponsor: Turkish Society of Colon and Rectal Surgery
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
Total mesorectal excision
Direct surgery without receiving neoadjuvant chemoradiotherapy
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)