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No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
Sponsor: Servicio de Salud Metropolitano Sur Oriente
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
Oxaliplatin
Consolidation Chemotherapy
5-Fluoracil
Consolidation Chemotherapy
Leucovorin
Consolidation Chemotherapy
Capecitabine
Consolidation Chemotherapy
5x5 Gy
Neoadjuvant Radiotherapy
Quality of Life Questionnaires
Quality of Life Evaluation (LARS Score, IIEF, FSFI, I-PSS and EORTC QLQ-C30)
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