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Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

NCT ID: NCT05916040

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-28

Study Completion Date

2030-06-30

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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Radiotherapy with MRIdian with simultaneous integrated boost

Intervention Type DEVICE

radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost

Questionnaires before, during and after radiotherapy

Intervention Type OTHER

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

Interventions

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Radiotherapy with MRIdian with simultaneous integrated boost

radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost

Intervention Type DEVICE

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

Intervention Type OTHER

Other Intervention Names

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Radiotherapy with MRIdian (ViewRay Inc.)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Mark De Ridder

Principal Investigator, Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark De Ridder, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel

Locations

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UZ Brussel - Dienst Radiotherapie

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Mark De Ridder, MD

Role: CONTACT

[email protected]
00324776041

Sven Van Laere, PhD

Role: CONTACT

[email protected]
00324776041

Facility Contacts

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Mark De Ridder, PhD, MD

Role: primary

[email protected]

Other Identifiers

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TNTRect

Identifier Type: -

Identifier Source: org_study_id