Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mid-Rectal Cancer | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Rectal Cancer Stage II | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer Stage III | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy followed by total mesorectal excision | Other | — | UNRESOLVED |
| Total mesorectal excision | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Upfront TME group
- description
- Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy
- interventionNames
- Other: Total mesorectal excision
- label
- Neoadjuvant chemoradiotherapy group
- description
- Patients who received neoadjuvant chemoradiotherapy before surgery
- interventionNames
- Other: Neoadjuvant Chemotherapy followed by total mesorectal excision
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- 3 years
- description
- The proportion of patients who remain free of disease recurrence (local or distant) three years after surgical intervention. DFS will be assessed through clinical evaluations, imaging studies, and pathology reports at regular follow-up intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * cT4 tumors * Stage IV disease * Patients with MSI (+) in TME pathology * PAtients who received neoadjuvant immunotherapy * Emergency surgery * Clinical obstruction * Previous pelvic radiotherapy * Patients treated without a multidisciplinary council decision * 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) * Synchronous colon tumors
References
Publications (4)
- BACKGROUNDPatel UB, Taylor F, Blomqvist L, George C, Evans H, Tekkis P, Quirke P, Sebag-Montefiore D, Moran B, Heald R, Guthrie A, Bees N, Swift I, Pennert K, Brown G. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol. 2011 Oct 1;29(28):3753-60. doi: 10.1200/JCO.2011.34.9068. Epub 2011 Aug 29. PMID 21876084
- BACKGROUNDRuppert R, Kube R, Strassburg J, Lewin A, Baral J, Maurer CA, Sauer J, Junginger T, Hermanek P, Merkel S; other members of the OCUM Group. Avoidance of Overtreatment of Rectal Cancer by Selective Chemoradiotherapy: Results of the Optimized Surgery and MRI-Based Multimodal Therapy Trial. J Am Coll Surg. 2020 Oct;231(4):413-425.e2. doi: 10.1016/j.jamcollsurg.2020.06.023. Epub 2020 Jul 19. PMID 32697965
- BACKGROUNDGlynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available. PMID 28881920
- DERIVEDKarakayali F, Arslan C, Bisgin T, Erenler Bayraktar I, Bayraktar O, Canda AE. Can neoadjuvant chemoradiotherapy be omitted in cT2N+ and cT3 mid-rectal cancer: Protocol for a prospective, observational, cohort study (CANO). PLoS One. 2025 Nov 5;20(11):e0321819. doi: 10.1371/journal.pone.0321819. eCollection 2025. PMID 41191581