Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer (CANO)

June 23, 2025 updated by: Turkish Society of Colon and Rectal Surgery

Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME) is the standard treatment for patients with locally advanced rectal cancer. This approach has been shown to improve local control and reduce recurrence rates. However, there is no clear evidence showing the advantage of neoadjuvant CRT in high and middle rectal tumors without involvement of mesorectal fascia (MRF). The MERCURY study demonstrated that preoperative MRI-predicted positive CRM is an independent factor for local recurrence. Following this study, the selective use of nCRT in patients at high risk of local recurrence has been proposed.

The ESMO guidelines indicate that T3a/b rectal tumors located above the levator muscles, without involvement of the circumferential resection margin (CRM) or extramural venous invasion (EMVI), are associated with a very low risk of local recurrence. Consequently, they suggest that upfront TME may be an appropriate treatment option for this subgroup of patients. This recommendation remains unchanged in the presence of lymph node involvement within the same group. For clinically staged cT3a/b mid- or high-rectal tumors with clear CRM and no evidence of EMVI, the routine use of nCRT remains a subject of debate. If the surgeon consistently performs high-quality total mesorectal excision (TME), upfront surgery may be a suitable treatment option for this subgroup of patients.

In line with these recommendations, some surgeons perform upfront TME for patients with T2-3 node-positive mid-rectal cancer in the absence of MRF involvement. However, in these cases, the common approach is to administer neoadjuvant chemoradiotherapy. This study seeks to observe whether upfront TME achieves similar 3-year disease-free survival compared to the standard approach of nCRT followed by TME in patients with cT2N+ and cT3Nx mid-rectal cancer without mesorectal fascia involvement.

Study Type

Observational

Enrollment (Estimated)

436

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Baskent University
        • Contact:
        • Principal Investigator:
          • Feza Karakayali, Prof.
      • Istanbul, Turkey
        • Memorial Sisli Hospital
        • Contact:
        • Principal Investigator:
          • Onur Bayraktar, Prof.
      • Istanbul, Turkey, 34394
        • Istanbul Health and Technology University
        • Contact:
        • Principal Investigator:
          • Cigdem N Arslan, Prof.
      • Izmir, Turkey
        • Dokuz Eylul University
        • Contact:
        • Principal Investigator:
          • Tayfun Bisgin, Assoc. Prof.
      • Izmir, Turkey
        • Acibadem Kent Hospital
        • Contact:
        • Principal Investigator:
          • Aras Emre Canda, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Upfront TME group
Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy
Other: Total mesorectal excision
Direct surgery without receiving neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy group
Patients who received neoadjuvant chemoradiotherapy before surgery
Other: Neoadjuvant Chemotherapy followed by total mesorectal excision
Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 and 5 years
The proportion of patients alive at 3 and 5 years post-treatment, regardless of disease status.
3 and 5 years
Local Recurrence Rate
Time Frame: 3 years and 5 years
The percentage of patients experiencing tumor recurrence at the primary site (anastomosis or pelvis) within 3 and 5 years.
3 years and 5 years
Colorectal Cancer Specific Quality of Life
Time Frame: Baseline, 1 year, 3 years and 5 years
Patient-reported outcomes assessed using the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire
Baseline, 1 year, 3 years and 5 years
Bowel Dysfunction Related Quality of Life
Time Frame: Baseline, 1 year, 3 years and 5 years
Patient-reported outcomes assessed using the low-anterior resection syndrome (LARS) score.
Baseline, 1 year, 3 years and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Society of Colon and Rectal Surgery

Collaborators

Baskent University
Dokuz Eylul University
Halic University
Acibadem Kent Hospital
Istanbul Health and Technology University

Investigators

  • Study Chair: Feza Karakayali, Prof., Baskent University
  • Principal Investigator: Aras Emre Canda, Prof., Acibadem Kent Hospital
  • Principal Investigator: Onur Bayraktar, Prof., Memorial Sisli Hospital
  • Principal Investigator: Tayfun Bisgin, Prof., Dokuz Eylul University
  • Principal Investigator: Ilknur Erenler Bayraktar, Prof., Halic University
  • Study Director: Cigdem N Arslan, Prof., Istanbul Health and Technology University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2035

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA24/461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, we plan to share de-identified individual participant data (IPD) related to primary and secondary outcomes. The data will be available to qualified researchers upon reasonable request, starting 6 months after publication of the study results and for up to 5 years. Data will be shared via a secure data repository, and access will require an approved data-sharing agreement

IPD Sharing Time Frame

6 months to 5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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