- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916040
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy (TNTRect)
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mark De Ridder, MD
- Phone Number: 00324776041
- Email: mark.deridder@uzbrussel.be
Study Contact Backup
- Name: Sven Van Laere, PhD
- Phone Number: 00324776041
- Email: sven.vanlaere@uzbrussel.be
Study Locations
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Brussels Capital Region
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Jette, Brussels Capital Region, Belgium, 1090
- Recruiting
- UZ Brussel - Dienst Radiotherapie
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Contact:
- Mark De Ridder, PhD, MD
- Email: mark.deridder@uzbrussel.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
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radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
Other Names:
Questionnaires consisting of 3 quality of life scales and 1 mental state scale:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to therapy
Time Frame: up to 25 weeks after start of radiotherapy
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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.
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up to 25 weeks after start of radiotherapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life assessment via QLQ-C30
Time Frame: from the start of radiotherapy until 5 years after treatment
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Quality of life according to EORTC Quality of life Questionnaire QLQ-C30
|
from the start of radiotherapy until 5 years after treatment
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Colorectal specific quality of life assessment via QLQ-CR29
Time Frame: from the start of radiotherapy until 5 years after treatment
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Colorectal specific quality of life according to EORTC Quality of life Questionnaire QLQ-CR29
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from the start of radiotherapy until 5 years after treatment
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Bowel functioning specific quality of life assessment via LARS score
Time Frame: from the start of radiotherapy until 5 years after treatment
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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
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Anxiety and depression state via HADS
Time Frame: from the start of radiotherapy until 5 years after treatment
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark De Ridder, MD, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TNTRect
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
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-
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