Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy (TNTRect)

December 3, 2024 updated by: Mark De Ridder, Universitair Ziekenhuis Brussel

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Brussels Capital Region
      • Jette, Brussels Capital Region, Belgium, 1090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with rectal cancer aged 18 years or older.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: Radiotherapy with MRIdian with simultaneous integrated boost
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
Other Names:
  • Radiotherapy with MRIdian (ViewRay Inc.)
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

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
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
Time Frame: from the start of radiotherapy until 5 years after treatment
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
Time Frame: from the start of radiotherapy until 5 years after treatment
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
Time Frame: 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.
from the start of radiotherapy until 5 years after treatment
Anxiety and depression state via HADS
Time Frame: 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.
from the start of radiotherapy until 5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Mark De Ridder, MD, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

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

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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