Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06823297

Noch nicht rekrutierend

CANO: Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer

Beobachtungsstudie

Phase nicht angegeben

Dokuz Eylul University

Sponsor: Turkish Society of Colon and Rectal Surgery

Zuletzt aktualisiert: 27. Juni 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere

Erforderliche Mutationen

Keine

Studie gestartet

1. August 2025

Zuletzt vom Sponsor aktualisiert

27. Juni 2025

Voraussichtlicher Abschluss

1. August 2030

Studienkontakt

Name:Cigdem N Arslan, Prof.

E-Mail:cigdemarslan@hotmail.it

Telefon:+905421454435

Name:Feza Karakayali, Prof.

E-Mail:fezaykar@yahoo.com

Telefon:+905421454435

Eignung

Einschlusskriterien

* 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

Ausschlusskriterien

* 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

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Design-Details

ZuteilungN/A

InterventionsmodellN/A

MaskierungN/A

Anzahl der Teilnehmer436

Arme & Interventionen

Arme

Interventionen

Typ: N/A

Beschreibung: Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy

Interventionen:

Total mesorectal excision
Neoadjuvant Chemotherapy followed by total mesorectal excision

Ergebnismessungen

Primäre Ergebnismessungen

Disease-free survival (DFS)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.

Sekundäre Ergebnismessungen

Overall Survival3 and 5 years

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

Local Recurrence Rate3 years and 5 years

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

Colorectal Cancer Specific Quality of LifeBaseline, 1 year, 3 years and 5 years

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

Bowel Dysfunction Related Quality of LifeBaseline, 1 year, 3 years and 5 years

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

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Studienzentren

Dokuz Eylul University

Izmir, TR

Name:Tayfun Bisgin, Assoc. Prof.

E-Mail:tayfun.bisgin@gmail.com

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