Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
Universitair Ziekenhuis Brussel
35 participants
Nov 28, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Locally advanced rectal cancer
Exclusion Criteria3
- Patients with unresectable metastatic disease at diagnosis
- Patients with an ECOG performance status \> 2
- Patients not deemed fit for radiotherapy, chemotherapy or surgery
Interventions
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05916040