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

NCT04864067 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-05-08

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • Servicio de Salud Metropolitano Sur Oriente

    lead OTHER_GOV

Principal Investigators

  • Felipe F Quezada-Diaz, MD · Complejo Asistencial Doctor Sótero del Rio

  • Nicole M Caire, MD · Complejo Asistencial Doctor Sótero Del Río

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864067 on ClinicalTrials.gov