Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTurkish Society of Colon and Rectal Surgery
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
cT4 tumors
Stage IV disease
Patients with MSI (+) in TME pathology
PAtients who received neoadjuvant immunotherapy
Trial design
Treatments tested in this trial
- Total mesorectal excision
- Neoadjuvant Chemotherapy followed by total mesorectal excision
Treatment groups
436 Participants
are divided into 2 treatment groupsSponsors and collaborators
Turkish Society of Colon and Rectal Surgery
Lead sponsor
Baskent University
Collaborator
Dokuz Eylul University
Collaborator
Halic University
Collaborator
Acibadem Kent Hospital
Collaborator
Istanbul Health and Technology University
Collaborator
Source ClinicalTrials.gov