MedTrace Logo

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

NCT05916040 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2024-12-04

No results posted yet for this study

Summary

The TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach.

The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life \& hospital anxiety and depression will be measured.

Conditions

Interventions

DEVICE

Radiotherapy with MRIdian with simultaneous integrated boost

radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost

OTHER

Questionnaires before, during and after radiotherapy

Questionnaires consisting of 3 quality of life scales and 1 mental state scale: * EORTC QLQ-C30 * EORTC QLQ-CR29 * Low Anterior Resection Syndrome Score (LARS) questionnaire * Hospital Anxiety and Depression Scale (HADS) questionnaire

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Mark De Ridder, MD · Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2025-06-30
Completion
2030-06-30
FDA Device
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

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 NCT05916040 on ClinicalTrials.gov