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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Locally advanced rectal cancer

Locations
Other Locations
Belgium
UZ Brussel - Dienst Radiotherapie
RECRUITING
Jette
Contact Information
Primary
Mark De Ridder, MD
mark.deridder@uzbrussel.be
00324776041
Backup
Sven Van Laere, PhD
sven.vanlaere@uzbrussel.be
00324776041
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 35
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov