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Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

ConditionsMid-Rectal CancerRectal Cancer Stage IIRectal Cancer Stage III
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTurkish Society of Colon and Rectal Surgery

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

cT4 tumors

Stage IV disease

Patients with MSI (+) in TME pathology

PAtients who received neoadjuvant immunotherapy

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Total mesorectal excision

    Other intervention

    Direct surgery without receiving neoadjuvant chemoradiotherapy

  • Neoadjuvant Chemotherapy followed by total mesorectal excision

    Other intervention

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

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: Upfront TME group1 intervention
Group B: Neoadjuvant chemoradiotherapy group1 intervention

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Overall Survival

The proportion of patients alive at 3 and 5 years post-treatment, regardless of disease status.

Time frame
3 and 5 years
2

Local Recurrence Rate

The percentage of patients experiencing tumor recurrence at the primary site (anastomosis or pelvis) within 3 and 5 years.

Time frame
3 years and 5 years
3

Colorectal Cancer Specific Quality of Life

Patient-reported outcomes assessed using the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire

Time frame
Baseline, 1 year, 3 years and 5 years
4

Bowel Dysfunction Related Quality of Life

Patient-reported outcomes assessed using the low-anterior resection syndrome (LARS) score.

Time frame
Baseline, 1 year, 3 years and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turkish Society of Colon and Rectal Surgery

Lead sponsor

Baskent University

Collaborator

Dokuz Eylul University

Collaborator

Halic University

Collaborator

Acibadem Kent Hospital

Collaborator

Istanbul Health and Technology University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: