Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

Rectal Cancer Clinical Trial

— TNTRect  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916040
• Other study ID #: TNTRect
• Status: Recruiting
• Start date: September 1, 2024
• Est. completion date: June 30, 2030

Study information

• Verified date: May 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Mark De Ridder, MD
• Phone: 00324776041
• Email: mark.deridder[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Radiotherapy with MRIdian with simultaneous integrated boost
radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost

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

Locations

Country	Name	City	State
Belgium	UZ Brussel - Dienst Radiotherapie	Jette	Brussels Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Quality of life assessment via QLQ-C30	Quality of life according to EORTC Quality of life Questionnaire QLQ-C30	from the start of radiotherapy until 5 years after treatment
Secondary	Colorectal specific quality of life assessment via QLQ-CR29	Colorectal specific quality of life according to EORTC Quality of life Questionnaire QLQ-CR29	from the start of radiotherapy until 5 years after treatment
Secondary	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.	from the start of radiotherapy until 5 years after treatment
Secondary	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.	from the start of radiotherapy until 5 years after treatment