Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy with MRIdian with simultaneous integrated boost, Questionnaires before, during and after radiotherapy.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
Overview
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.
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
Primary outcome measures
- Response to therapy [Time frame: up to 25 weeks after start of radiotherapy]
Secondary outcome measures (4)
- Quality of life assessment via QLQ-C30 [Time frame: from the start of radiotherapy until 5 years after treatment]
- Colorectal specific quality of life assessment via QLQ-CR29 [Time frame: from the start of radiotherapy until 5 years after treatment]
- Bowel functioning specific quality of life assessment via LARS score [Time frame: from the start of radiotherapy until 5 years after treatment]
- Anxiety and depression state via HADS [Time frame: from the start of radiotherapy until 5 years after treatment]
Eligibility criteria
Inclusion criteria
- Locally advanced rectal cancer
Exclusion criteria
- Patients with unresectable metastatic disease at diagnosis
- Patients with an ECOG performance status > 2
- Patients not deemed fit for radiotherapy, chemotherapy or surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- UZ Brussel - Dienst Radiotherapie — Jette
Identifiers
NCT: NCT05916040 · TNTRect