TNTRect: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TNTRect MRI-guided radiotherapy group 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. |
Device: Radiotherapy with MRIdian with simultaneous integrated boost
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
Other Names:
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Locally advanced rectal cancer
Exclusion Criteria:
-
Patients with unresectable metastatic disease at diagnosis
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Patients with an ECOG performance status > 2
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Patients not deemed fit for radiotherapy, chemotherapy or surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Mark De Ridder, MD, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TNTRect