Clinical Trial

MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)

Study acronym: MARGARITA
Recruiting
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Record status
This record was last updated July 18, 2023 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to explore the effectiveness and side effects of a high dose daily adapted SBRT (stereotactic body radiotherapy) boost delivered with MRLinac in patients with gynaecological cancers that cannot receive a brachytherapy boost to the primary tumour for different reasons (medical conditions, tumour extensions, etc). Current alternative for brachytherapy in these situations is often a non-adaptive conebeam- CT guided boost. Conebeam-CT guided non-adaptive high dose SBRT in under these circumstances is described being quite toxic. The main questions this study aims to answer are: * In how many cases could local control (i.e. total disappearance of the tumor) is be achieved with this treatment? * Which side effects are observed in patients receiving this treatment? Participants will be asked to fill out questionnaires (e.g. regarding side effects). Furthermore, participants are asked if their clinical data may be used for study purposes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-30.
Trial Details
NCT Number NCT05937958
Lead Sponsor UMC Utrecht
Collaborators: Odense University Hospital
Conditions Cervical Cancer, Gynecologic Cancer
Enrollment 30 participants
Start Date 2023-04-01
Primary Completion 2025-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2023-07-18