Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: Radiotherapy with MRIdian with simultaneous integrated boost
* Other: Questionnaires before, during and after radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TNTRect MRI-guided radiotherapy group with simultaneous integrated boost<br>Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer. | Device: Radiotherapy with MRIdian with simultaneous integrated boost<br>* radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost<br>* Other names: Radiotherapy with MRIdian (ViewRay Inc.);Other: Questionnaires before, during and after radiotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to therapy | 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. | up to 25 weeks after start of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment via QLQ-C30 | Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 | from the start of radiotherapy until 5 years after treatment | 
| Colorectal specific quality of life assessment via QLQ-CR29 | Colorectal specific quality of life according to EORTC Quality of life Questionnaire QLQ-CR29 | from the start of radiotherapy until 5 years after treatment | 
| Bowel functioning specific quality of life assessment via LARS score | 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. | from the start of radiotherapy until 5 years after treatment | 
| Anxiety and depression state via HADS | 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. | from the start of radiotherapy until 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation therapy, MR-guided radiotherapy, Stereotactic body radiotherapy, Total Neo-adjuvant Treatment