Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
- Conditions
- Rectal Cancer
- Interventions
- Device: Radiotherapy with MRIdian with simultaneous integrated boostOther: Questionnaires before, during and after radiotherapy
- Registration Number
- NCT05916040
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- Locally advanced rectal cancer
- Patients with unresectable metastatic disease at diagnosis
- Patients with an ECOG performance status > 2
- Patients not deemed fit for radiotherapy, chemotherapy or surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TNTRect MRI-guided radiotherapy group with simultaneous integrated boost Radiotherapy with MRIdian with simultaneous integrated boost Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer. TNTRect MRI-guided radiotherapy group with simultaneous integrated boost Questionnaires before, during and after radiotherapy Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer.
- Primary Outcome Measures
Name Time Method Response to therapy up to 25 weeks after start of radiotherapy After radiotherapy and chemotherapy are administered, the patient will be evaluated for a potential watchful-waiting approach where, together with the patient, can be opted too not perform a TME (total mesorectal excision). This outcome measure registers if the therapy works.
- Secondary Outcome Measures
Name Time Method Quality of life assessment via QLQ-C30 from the start of radiotherapy until 5 years after treatment Quality of life according to EORTC Quality of life Questionnaire QLQ-C30
Colorectal specific quality of life assessment via QLQ-CR29 from the start of radiotherapy until 5 years after treatment Colorectal specific quality of life according to EORTC Quality of life Questionnaire QLQ-CR29
Bowel functioning specific quality of life assessment via LARS score from the start of radiotherapy until 5 years after treatment Bowel functioning quality of life according to Emmertsen and Lauberg's\[1\] Quality of life Questionnaire LARS.
\[1\]: Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012;255:922-8.
In that scientific publication, the authors introduced a practical and psychometrically robust instrument for examining bowel function (after surgery in rectal cancer), which reflects impact on quality of life.Anxiety and depression state via HADS from the start of radiotherapy until 5 years after treatment Hospital Anxiety and Depression Scale (HADS) according to Zigmond and Snaith \[2\].
\[2\]: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.
In that scientific publication, the authors introduced a self-assessment scale to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.
Trial Locations
- Locations (1)
UZ Brussel - Dienst Radiotherapie
🇧🇪Jette, Brussels Capital Region, Belgium