Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

NCT06823297 | Not Yet Recruiting DMC

• 1 other identifier: KA24/461
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Mid-Rectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III

Keywords

Mid-Rectal Cancer; Radiotherapy; Mesorectal fascia

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  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.

  3 years

Secondary Outcomes (4)

• Overall Survival

  3 and 5 years

• Local Recurrence Rate

  3 years and 5 years

• Colorectal Cancer Specific Quality of Life

  Baseline, 1 year, 3 years and 5 years

• Bowel Dysfunction Related Quality of Life

  Baseline, 1 year, 3 years and 5 years

Study Arms (2)

Upfront TME group

Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy

Other: Total mesorectal excision

Neoadjuvant chemoradiotherapy group

Patients who received neoadjuvant chemoradiotherapy before surgery

Other: Neoadjuvant Chemotherapy followed by total mesorectal excision

Interventions

Total mesorectal excision OTHER

Direct surgery without receiving neoadjuvant chemoradiotherapy

Upfront TME group

Neoadjuvant Chemotherapy followed by total mesorectal excision OTHER

Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery

Neoadjuvant chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Histologically proven rectal cancer patients with locally advanced disease (cT2N0-T3N0-N+), but without distant metastases or high-risk features such as mesorectal fascia involvement, lateral nodes, EMVI or adjacent organ invasion (cT4).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish Society of Colon and Rectal Surgery: lead
• Baskent University: collaborator
• Dokuz Eylul University: collaborator
• Halic University: collaborator
• Acibadem Kent Hospital: collaborator
• Istanbul Health and Technology University: collaborator

Study Sites (5)

Baskent University

Ankara, Turkey (Türkiye)

Location

Istanbul Health and Technology University

Istanbul, 34394, Turkey (Türkiye)

Location

Memorial sisli Hospital

Istanbul, Turkey (Türkiye)

Location

Acibadem Kent Hospital

Izmir, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• Patel 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 BACKGROUND

• Ruppert 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 BACKGROUND

• Glynne-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 BACKGROUND

• Karakayali 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 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Feza Karakayali, Prof.

  Baskent University

  STUDY CHAIR

• Aras Emre Canda, Prof.

  Acibadem Kent Hospital

  PRINCIPAL INVESTIGATOR

• Ilknur Erenler Bayraktar, Prof.

  Halic University

  PRINCIPAL INVESTIGATOR

• Onur Bayraktar, Prof.

  Memorial Sisli Hospital

  PRINCIPAL INVESTIGATOR

• Cigdem N Arslan, Prof.

  Istanbul Health and Technology University

  STUDY DIRECTOR

• Tayfun Bisgin, Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cigdem N Arslan, Prof.

CONTACT

+905421454435; cigdemarslan@hotmail.it

Feza Karakayali, Prof.

CONTACT

+905421454435; fezaykar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2035
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months to 5 years

Locations

TU (5)