MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Recruiting now
Conditions studied: Cervical Cancer, Gynecologic Cancer
In brief
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.
Key facts
- Study ID
- NCT05937958
- Run by
- UMC Utrecht
- People needed
- 30
- Starts
- 2023-04-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2023-07-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with newly biopsy proven advanced stage gynecological cancers (excluding ovarian cancers) and endometrium in whom definitive (chemo)radiotherapy with curative intent is planned are qualified for the study, as well as, patients with recurrent gynecological cancers (excluding ovarian cancers) for which no prior (chemo)radiation was performed for which (chemo)radiotherapy with curative intent is planned.
- Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 are also eligible but patients with further dissemination are not.
- Staging according to FIGO (2018, https://doi.org/10.1002/ijgo.12611) and TNM (version 9, 2021, https://doi.org/10.3322/caac.21663) staging.
- Patients who gave informed consent to take part in the MOMENTUM study (NCT04075305) to use their clinical data for publication and share their data with other (European) sites.
You may not qualify if…
- Hard contra-indication for MRI scanning
Where it is running
- Odense University Hospital — Odense, Denmark (enrolling)
- UMC Utrecht — Utrecht, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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