Spots Global Cancer Trial Database for Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
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Trial Identification
Brief Title: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Official Title: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
Study ID: NCT05916040
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UZ Brussel - Dienst Radiotherapie, Jette, Brussels Capital Region, Belgium
Contact Details
Name: Mark De Ridder, MD
Affiliation: Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Role: PRINCIPAL_INVESTIGATOR
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