Clinical trial · Observational
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Local control
- timeFrame
- 3 months after MRLinac treatment
- description
- Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
- measure
- Local control
- timeFrame
- 6 months after MRLinac treatment
- description
- Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
- measure
- Local control
- timeFrame
- 12 months after MRLinac treatment
- description
- Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
L Edwards, H Tan, K Rahim et al. · J Med Imaging Radiat Oncol · Sep 12, 2026 · PMID 42730749 pubmed