Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06823297

Aún no recluta

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

Observacional

Fase no especificada

Dokuz Eylul University

Patrocinador: Turkish Society of Colon and Rectal Surgery

Última actualización: 27 de junio de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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.

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Categoría de tratamiento

Otros

Erforderliche Mutationen

Ninguna

Ensayo iniciado

1 de agosto de 2025

Última actualización por el patrocinador

27 de junio de 2025

Finalización estimada

1 de agosto de 2030

Contacto del estudio

Nombre:Cigdem N Arslan, Prof.

Correo electrónico:cigdemarslan@hotmail.it

Teléfono:+905421454435

Nombre:Feza Karakayali, Prof.

Correo electrónico:fezaykar@yahoo.com

Teléfono:+905421454435

Elegibilidad

Criterios de inclusión

* 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

Criterios de exclusión

* 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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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónN/A

EnmascaramientoN/A

Número a inscribir436

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: N/A

Descripción: Patients who underwent surgery without receiving neoadjuvant chemoradiotherapy

Intervenciones:

Total mesorectal excision
Neoadjuvant Chemotherapy followed by total mesorectal excision

Medidas de resultado

Medidas de resultado primarias

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.

Medidas de resultado secundarias

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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Sitios del ensayo

Dokuz Eylul University

Izmir, TR

Nombre:Tayfun Bisgin, Assoc. Prof.

Correo electrónico:tayfun.bisgin@gmail.com

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