Mid-Rectal CancerCANONCT06823297
Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer
An observational study of Mid-Rectal Cancer and Rectal Cancer Stage II, run by Turkish Society of Colon and Rectal Surgery at 5 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mid-Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- What is being tested?
- Total mesorectal excision and Neoadjuvant Chemotherapy followed by total mesorectal excision
- How many people
- 436 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Aug 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- cT4 tumors
- Stage IV disease
- Patients with MSI (+) in TME pathology
- PAtients who received neoadjuvant immunotherapy
- Emergency surgery
- Clinical obstruction
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites
Baskent University
Ankara
Feza Karakayali, Prof., fezaykar@yahoo.com
Feza Karakayali, Prof.
Istanbul Health and Technology University
Istanbul, 34394
Cigdem N Arslan, Prof., cigdemarslan@hotmail.it
Cigdem N Arslan, Prof.
Memorial sisli Hospital
Istanbul
Onur Bayraktar, Prof., dronurbayraktar@gmail.com
Onur Bayraktar, Prof.
Acibadem Kent Hospital
Izmir
Aras Emre Canda, Prof, candaae@gmail.com
Aras Emre Canda, Prof.
Dokuz Eylul University
Izmir
Tayfun Bisgin, Assoc. Prof., tayfun.bisgin@gmail.com
Tayfun Bisgin, Assoc. Prof.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Total mesorectal excision, Neoadjuvant Chemotherapy followed by total mesorectal excision
- Keywords
- Mid-Rectal Cancer, Radiotherapy, Mesorectal fascia
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total mesorectal excisionOther
Direct surgery without receiving neoadjuvant chemoradiotherapy
Neoadjuvant Chemotherapy followed by total mesorectal excisionOther
Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery
| Study group | Role | What they receive |
|---|---|---|
| Upfront TME group | Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy Receives: Other: Total mesorectal excision | |
| Neoadjuvant chemoradiotherapy group | Patients who received neoadjuvant chemoradiotherapy before surgery Receives: Other: Neoadjuvant Chemotherapy followed by total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
Overall Survival
The proportion of patients alive at 3 and 5 years post-treatment, regardless of disease status.
Measured: 3 and 5 years
Local Recurrence Rate
The percentage of patients experiencing tumor recurrence at the primary site (anastomosis or pelvis) within 3 and 5 years.
Measured: 3 years and 5 years
Colorectal Cancer Specific Quality of Life
Patient-reported outcomes assessed using the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire
Measured: Baseline, 1 year, 3 years and 5 years
Bowel Dysfunction Related Quality of Life
Patient-reported outcomes assessed using the low-anterior resection syndrome (LARS) score.
Measured: Baseline, 1 year, 3 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mid-Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 436 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Turkish Society of Colon and Rectal Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University, Dokuz Eylul University, Halic University, Acibadem Kent Hospital, Istanbul Health and Technology University
- Responsible party
- Sponsor
- Investigators
- Feza Karakayali, Prof., Study chair, Baskent UniversityAras Emre Canda, Prof., Principal investigator, Acibadem Kent HospitalIlknur Erenler Bayraktar, Prof., Principal investigator, Halic UniversityOnur Bayraktar, Prof., Principal investigator, Memorial Sisli HospitalCigdem N Arslan, Prof., Study director, Istanbul Health and Technology UniversityTayfun Bisgin, Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823297
- Sponsor's protocol ID
- KA24/461
- Acronym
- CANO
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 21876084Ruppert 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.
PubMed 32697965Glynne-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.
PubMed 28881920Karakayali 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.
PubMed 41191581
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06823297
- Acronym / sponsor ID
- CANO / KA24/461
- Keywords
- Mid-Rectal Cancer, Radiotherapy, Mesorectal fascia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Turkish Society of Colon and Rectal SurgeryUniversity, hospital or other
- Collaborators
- Baskent University, Dokuz Eylul University, Halic University, Acibadem Kent Hospital, Istanbul Health and Technology University
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2035 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront TME group | – | Other: Total mesorectal excisionPatients who underwent surgery without receiving neoadjuvant chemoradiotherapy |
| Neoadjuvant chemoradiotherapy group | – | Other: Neoadjuvant Chemotherapy followed by total mesorectal excisionPatients who received neoadjuvant chemoradiotherapy before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- cT4 tumors
- Stage IV disease
- Patients with MSI (+) in TME pathology
- PAtients who received neoadjuvant immunotherapy
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total mesorectal excisionDirect surgery without receiving neoadjuvant chemoradiotherapy | Other | Upfront TME group |
| Neoadjuvant Chemotherapy followed by total mesorectal excisionNeoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery | Other | Neoadjuvant chemoradiotherapy group |
Primary outcome
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.
4 secondary outcomes
Overall Survival
Time frame: 3 and 5 years
Local Recurrence Rate
Time frame: 3 years and 5 years
Colorectal Cancer Specific Quality of Life
Time frame: Baseline, 1 year, 3 years and 5 years
Bowel Dysfunction Related Quality of Life
Time frame: Baseline, 1 year, 3 years and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 21876084Patel 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.
- Background: PubMed 32697965Ruppert 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.
- Background: PubMed 28881920Glynne-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.
- Derived from this study: PubMed 41191581Karakayali 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Mid-Rectal Cancer
Not yet recruitingPhase 3
Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Rectal Cancer
Rectal Cancer
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer
RecruitingPhase 2/3
Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
Rectal Cancer, Neoadjuvant Therapies
Not yet recruiting
Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East
Colonoscopy, Colorectal Cancer Screening
Not yet recruiting
Preoperative Nasal Intestinal Obstruction Catheter Mediated Terminal Ileum Fecal Diversion Versus Intraoperative Protective Ileostomy for Preventing Anastomotic Leakage After Mid Low Rectal Cancer Surgery: A Non Inferiority, Prospective, Multicenter Randomized Controlled Trial
Rectal Cancer Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feza Karakayali, Prof. study chair
Baskent University
Aras Emre Canda, Prof. principal investigator
Acibadem Kent Hospital
Ilknur Erenler Bayraktar, Prof. principal investigator
Halic University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mid-Rectal Cancer and Rectal Cancer Stage II, run by Turkish Society of Colon and Rectal Surgery at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cigdem N Arslan, Prof. (+905421454435, cigdemarslan@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823297, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.