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ACTIVE NOT RECRUITING
NCT04864067
PHASE2

No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer

Sponsor: Servicio de Salud Metropolitano Sur Oriente

View on ClinicalTrials.gov

Summary

This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (\>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).

Official title: No Operation After Short Course Equivalent Dose (Ht) Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer: The Prospective, Single Arm NOAHS-ARC Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

73

Start Date

2021-06-09

Completion Date

2026-03-01

Last Updated

2025-07-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Oxaliplatin

Consolidation Chemotherapy

DRUG

5-Fluoracil

Consolidation Chemotherapy

DRUG

Leucovorin

Consolidation Chemotherapy

DRUG

Capecitabine

Consolidation Chemotherapy

RADIATION

5x5 Gy

Neoadjuvant Radiotherapy

BEHAVIORAL

Quality of Life Questionnaires

Quality of Life Evaluation (LARS Score, IIEF, FSFI, I-PSS and EORTC QLQ-C30)

PROCEDURE

DRE/ Endoscopy

Flexible Sigmoidoscopy and Digital Rectal Exam

Locations (3)

Complejo Asistencial Doctor Sótero del Rio

Santiago, RM, Chile

Hospital La Florida

Santiago, RM, Chile

Hospital Padre Hurtado

Santiago, RM, Chile