Actively Recruiting

Age: 18Years +
All Genders
NCT05916040

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

Led by Universitair Ziekenhuis Brussel · Updated on 2024-12-04

35

Participants Needed

1

Research Sites

291 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Locally advanced rectal cancer
Not Eligible

You will not qualify if you...

  • Patients with unresectable metastatic disease at diagnosis
  • Patients with an ECOG performance status > 2
  • Patients not deemed fit for radiotherapy, chemotherapy or surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

UZ Brussel - Dienst Radiotherapie

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

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Research Team

M

Mark De Ridder, MD

CONTACT

S

Sven Van Laere, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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