MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Recruiting
Observational Study
Cervical CancerGynecologic Cancer
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
30 (estimated)
Sponsor
UMC Utrecht · Other
Who this trial is looking for
This trial is looking for patients with advanced gynecological cancers who cannot receive a specific type of treatment called brachytherapy. Participants will receive a different type of radiation therapy and will be asked to fill out questionnaires about their experience.
Are You a Good Fit for This Trial?
You may be able to join if
I have a biopsy-proven advanced stage gynecological cancer
I have a recurrent gynecological cancer and have not had prior radiation
I have para-aortic metastatic nodes (stage IVB) to the level of L2
I have given informed consent to take part in the MOMENTUM study
You may not be able to join if
I have a hard contraindication for MRI scanning
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 (exc…
Inclusion Criteria:
* 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 Criteria:
* Hard contra-indication for MRI scanning
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