NCT06823297Not yet recruiting
Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer
Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 436 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2030
- Lead sponsor
- Turkish Society of Colon and Rectal Surgery
- Diseases
- Colorectal cancer
- NCT number
- NCT06823297
What you commit to
- Study type: Observational
- Planned participants: 436
- From 1 Aug 2025 to the primary completion date, 1 Aug 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PAtients who received neoadjuvant immunotherapy
- Emergency surgery
- Previous pelvic radiotherapy
Other illness
- Stage IV disease
- 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)
Other
- cT4 tumors
- Patients with MSI (+) in TME pathology
- Clinical obstruction
- Patients treated without a multidisciplinary council decision
- Synchronous colon tumors
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baskent University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Istanbul Health and Technology University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Memorial Sisli Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Acibadem Kent Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Dokuz Eylul University Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.