Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05916040

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel - Dienst Radiotherapie

Jette, Brussels Capital, 1090, Belgium

Location status: Recruiting

Location contact

Mark De Ridder, PhD, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy with MRIdian with simultaneous integrated boost

Device

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

Other names: Radiotherapy with MRIdian (ViewRay Inc.)

Questionnaires before, during and after radiotherapy

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark De Ridder, MD

CONTACT

[email protected]

00324776041

Sven Van Laere, PhD

CONTACT

[email protected]

00324776041

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study

Acronym: TNTRect

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Jun 23, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.