drugset / Trial / NCT04864067

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

NCT04864067 ↗

Phase 2 Completed 39 enrolled Servicio de Salud Metropolitano Sur Oriente
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-06-09
Primary completion
2026-05-05
Completion
2026-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject 5-Fluoracil Unknown — —
Subject Capecitabine Small molecule — —
Subject Leucovorin Small molecule — —
Subject Oxaliplatin Small molecule — —

Indications