MRLinac Boost Radiotherapy for Gynecological Cancers Unable to Receive Brachytherapy
Studies a high-dose MRLinac radiotherapy boost in adults with gynecological cancers who cannot have brachytherapy.
Plain-language title generated from the registry record
Registry title: MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Key facts
- Where
- Odense, DenmarkSee the site
Where in Denmark
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT05937958
- Record updated
- 18 July 2023
- Original description
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.Read full original descriptionShow less
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
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.
Inclusion: 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.
Exclusion: Hard contra-indication for MRI scanning.