Actively Recruiting
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Led by UMC Utrecht · Updated on 2023-07-18
30
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly biopsy-proven advanced stage gynecological cancers (excluding ovarian cancer) or endometrial cancer planning definitive chemoradiotherapy with curative intent
- Patients with recurrent gynecological cancers (excluding ovarian cancer) without prior chemoradiation, planning curative chemoradiotherapy
- Patients with para-aortic metastatic lymph nodes up to the level of L2 (stage IVB) are eligible
- Staging according to FIGO 2018 and TNM version 9 (2021) criteria
- Patients who gave informed consent to participate in the MOMENTUM study (NCT04075305) for data use and sharing
You will not qualify if you...
- Patients with a hard contraindication for MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Odense University Hospital
Odense, Denmark
Actively Recruiting
2
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
V
van Lier, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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