NCT05916040|RecruitingFDA Device
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
TNTRect
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TNTRect
Sponsor study identifier
observational
35
1 country
1
Study Start
November 28, 2024
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 24, 2023
Actual (reported)June 23, 2023
Actual (reported)November 28, 2024
Actual (reported)June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Quality of life assessment via QLQ-C30
from the start of radiotherapy until 5 years after treatment
Colorectal specific quality of life assessment via QLQ-CR29
from the start of radiotherapy until 5 years after treatment
Bowel functioning specific quality of life assessment via LARS score
from the start of radiotherapy until 5 years after treatment
Anxiety and depression state via HADS
from the start of radiotherapy until 5 years after treatment
Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer.
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
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
Patients diagnosed with rectal cancer aged 18 years or older.
UZ Brussel - Dienst Radiotherapie
Jette, Brussels Capital, 1090, Belgium
Mark De Ridder, MD
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
First Submitted
May 24, 2023
First Posted
June 23, 2023
Study Start
November 28, 2024
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 4, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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