NCT05916040

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-28
• Primary completion: 2025-06-30
• Completion: 2030-06-30
• First posted: 2023-06-23
• Last updated: 2024-12-04

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study