Rectal CancerTNTRectNCT05916040
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
An observational study of Rectal Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Radiotherapy with MRIdian with simultaneous integrated boost and Questionnaires before, during and after radiotherapy
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Nov 2024to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with rectal cancer aged 18 years or older.
Who may be able to join
- Locally advanced rectal cancer
Who cannot join
- Patients with unresectable metastatic disease at diagnosis
- Patients with an ECOG performance status > 2
- Patients not deemed fit for radiotherapy, chemotherapy or surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel - Dienst Radiotherapie
Jette, Brussels Capital, 1090
Mark De Ridder, PhD, MD, mark.deridder@uzbrussel.be
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Being tested
- Radiotherapy with MRIdian with simultaneous integrated boost, Questionnaires before, during and after radiotherapy
- Keywords
- Radiation therapy, MR-guided radiotherapy, Stereotactic body radiotherapy, Total Neo-adjuvant Treatment
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy with MRIdian with simultaneous integrated boostDevice
Also called Radiotherapy with MRIdian (ViewRay Inc.)
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
Questionnaires before, during and after radiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Radiotherapy with MRIdian with simultaneous integrated boost; Other: Questionnaires before, during and after radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 25 weeks after start of radiotherapy
Secondary outcomes (4)
Quality of life assessment via QLQ-C30
Quality of life according to EORTC Quality of life Questionnaire QLQ-C30
Measured: from the start of radiotherapy until 5 years after treatment
Colorectal specific quality of life assessment via QLQ-CR29
Colorectal specific quality of life according to EORTC Quality of life Questionnaire QLQ-CR29
Measured: from the start of radiotherapy until 5 years after treatment
Bowel functioning specific quality of life assessment via LARS score
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.
Measured: from the start of radiotherapy until 5 years after treatment
Anxiety and depression state via HADS
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.
Measured: from the start of radiotherapy until 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start28 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark De Ridder, Universitair Ziekenhuis Brussel
- Investigators
- Mark De Ridder, MD, Principal investigator, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916040
- Sponsor's protocol ID
- TNTRect
- Acronym
- TNTRect
- Status last verified
- Dec 2024
- First submitted
- 24 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05916040
- Acronym / sponsor ID
- TNTRect / TNTRect
- Conditions
- Rectal Cancer
- Keywords
- Radiation therapy, MR-guided radiotherapy, Stereotactic body radiotherapy, Total Neo-adjuvant Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNTRect MRI-guided radiotherapy group with simultaneous integrated boost | – | Device: Radiotherapy with MRIdian with simultaneous integrated boost, Other: Questionnaires before, during and after radiotherapyInterventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with rectal cancer aged 18 years or older.
Key inclusion criteria (1 listed)
- Locally advanced rectal cancer
Key exclusion criteria (3 listed)
- Patients with unresectable metastatic disease at diagnosis
- Patients with an ECOG performance status > 2
- Patients not deemed fit for radiotherapy, chemotherapy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy with MRIdian with simultaneous integrated boostAlso: Radiotherapy with MRIdian (ViewRay Inc.)radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost | Device | TNTRect MRI-guided radiotherapy group with simultaneous integrated boost |
| Questionnaires before, during and after radiotherapyQuestionnaires 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 | Other | TNTRect MRI-guided radiotherapy group with simultaneous integrated boost |
Primary outcome
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.
4 secondary outcomes
Quality of life assessment via QLQ-C30
Time frame: 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
Bowel functioning specific quality of life assessment via LARS score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark De Ridder, MD principal investigator
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark De Ridder, MD (00324776041, mark.deridder@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to therapy (time frame: up to 25 weeks after start of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.