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Oncology & Cancer Care
Opening soonObservationalNCT06823297

Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

Chemoradiotherapy before rectal cancer surgery has side effects, and some patients may not need it. This study follows people with mid-rectal cancer at low risk of local recurrence to see whether skipping it before surgery affects cancer control and bowel function.

SponsorTurkish Society of Colon and Rectal Surgery
Study typeObservational
Started2025-08-01
Primary completion2030-08-01
Planned enrolment436
Sites1 Acıbadem · 4 other

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

What this study is about

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.

+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 patient...

Conditions
  • Mid-Rectal Cancer
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III
Interventions
  • Total mesorectal excision
  • Neoadjuvant Chemotherapy followed by total mesorectal excision
Primary outcome measures
  • Disease-free survival (DFS) — 3 years
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
* 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
* 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

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Kent Hospital, Izmir

Also running at 4 other sites in 1 countries.

Source: ClinicalTrials.gov NCT06823297 · last updated 2025-06-27 · View registry record ↗