Clinical Research Directory
Browse clinical research sites, groups, and studies.
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Sponsor: Universitair Ziekenhuis Brussel
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.
Official title: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
35
Start Date
2024-11-28
Completion Date
2030-06-30
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
Radiotherapy with MRIdian with simultaneous integrated boost
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
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
Locations (1)
UZ Brussel - Dienst Radiotherapie
Jette, Brussels Capital, Belgium