Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer
NCT ID: NCT06823297
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
436 participants
OBSERVATIONAL
2025-08-01
2035-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Total Neoadjuvant Treatment vs. Chemoradiotherapy in Local Advanced Rectal Cancer With High Risk Factors
NCT03177382
Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
NCT03573791
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
NCT06566222
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
NCT04664504
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
NCT06599827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Upfront TME group
Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy
Total mesorectal excision
Direct surgery without receiving neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy group
Patients who received neoadjuvant chemoradiotherapy before surgery
Neoadjuvant Chemotherapy followed by total mesorectal excision
Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total mesorectal excision
Direct surgery without receiving neoadjuvant chemoradiotherapy
Neoadjuvant Chemotherapy followed by total mesorectal excision
Neoadjuvant chemoradiotherapy treatment regimens (including conventional chemoradiotherapy/radiotherapy/chemotherapy regimens or total neoadjuvant chemoradiotherapy regimens) before surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baskent University
OTHER
Dokuz Eylul University
OTHER
Halic University
OTHER
Acibadem Kent Hospital
OTHER
Istanbul Health and Technology University
OTHER
Turkish Society of Colon and Rectal Surgery
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Feza Karakayali, Prof.
Role: STUDY_CHAIR
Baskent University
Aras Emre Canda, Prof.
Role: PRINCIPAL_INVESTIGATOR
Acibadem Kent Hospital
Ilknur Erenler Bayraktar, Prof.
Role: PRINCIPAL_INVESTIGATOR
Halic University
Onur Bayraktar, Prof.
Role: PRINCIPAL_INVESTIGATOR
Memorial Sisli Hospital
Cigdem N Arslan, Prof.
Role: STUDY_DIRECTOR
Istanbul Health and Technology University
Tayfun Bisgin, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baskent University
Ankara, , Turkey (Türkiye)
Istanbul Health and Technology University
Istanbul, , Turkey (Türkiye)
Memorial sisli Hospital
Istanbul, , Turkey (Türkiye)
Acibadem Kent Hospital
Izmir, , Turkey (Türkiye)
Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KA24/461
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.