Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy (TNTRect)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Other: Questionnaires before, during and after radiotherapy; Device: Radiotherapy with MRIdian with simultaneous integrated boost

Study type: Observational

Funder types: Other

Identifiers

NCT05916040

TNTRect

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

TNTRect MRI-guided radiotherapy group with simultaneous integrated boost

Description:

Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer.

Treatment:

Device: Radiotherapy with MRIdian with simultaneous integrated boost

Other: Questionnaires before, during and after radiotherapy