NCT05937958Recruiting
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
Source: ClinicalTrials.gov · Last updated 18 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jun 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- UMC Utrecht
- Diseases
- Cervical cancer
- NCT number
- NCT05937958
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Apr 2023 to the primary completion date, 1 Oct 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Hard contra-indication for MRI scanning
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
Related publications
- MRI-Guided SBRT Boost for Patients With Locally Advanced Cervical Cancer Who Are Unsuitable for Standard of Care Image-Guided Brachytherapy.J Med Imaging Radiat Oncol · 2026 · PMID 42730749
This page is information, not medical advice. Discuss any trial with your doctor.