Cervical CancerMARGARITANCT05937958
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
An observational study of Cervical Cancer and Gynecologic Cancer, run by UMC Utrecht at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Gynecologic Cancer
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2023to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Hard contra-indication for MRI scanning
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense
Tine Schytte, PhD, MD
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Astrid van Lier, PhD, + 31 88 755 8800, a.l.h.m.w.vanlier@umcutrecht.nl
Ina Schulz, PhD,MD, +31 88 755 8800
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
Standard treatment of locally advanced cervical cancer is chemoradiotherapy (external beam radiotherapy (EBRT) and concomitant chemotherapy with weekly Cisplatin) followed by image guided brachytherapy (IGBT). Recently, the MR Linac has emerged as new option for delivering an external beam radiotherapy boost to the primary cervical tumour after (chemo)radiaton in case brachytherapy is not feasible. MR Linac in these cases can replace traditional EBRT boosts and allow for better visualisation of the anatomy, smaller treatment margins and online treatment planning adaptation. This comes with potential for higher dose to the target and less dose to the surrounding organs.
Like in IGBT, an MRL treatment provides the possibility to perform repetitive imaging before and even during each fraction and allows for dose adaptation to anatomical changes in individual patients. This way not not only the daily position of OARs in relation to the target can be taken into account, but also possible tumor regression which often is obtained during chemoradiation. Based on the experience collected so far, the MRL treatment may be an interesting treatment option in selected cases as daily MRI and plan adaptation leads to more confined dose distribution compared to CBCT-Linac options. However, dose levels for the MRL-boost are likely to be lower than for IGBT, therefore its effectiveness is still unsure.
Aims of the study:
- To introduce MRL-boost in locally advanced cervical cancer in a multicenter setting within the frame of a prospective observational study.
- To establish a bench-mark for clinical outcome with MRL-boost in a multi-center patient population with respect to local control, survival and toxicity.
- To establish reference material with regard to MRL-based DVH parameters; if applicable delineations according to the guidelines from the GEC-ESTRO gynecology working group will be used.
- To report image-based DVH parameters for target (GTV, CTV, PTV) and for OARs
- To report recurrence patterns
- To report Quality of Life
Type of design
This study is a multicenter prospective observational study. Patient registration and dosimetric reporting will be performed in the individual centers.
- Conditions
- Cervical Cancer, Gynecologic Cancer
- Keywords
- Radiotherapy, MRLinac, Gynecologic Cancer, Local control, Toxicity, Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 3 months after MRLinac treatment
Local control
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 6 months after MRLinac treatment
Local control
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 12 months after MRLinac treatment
Local control
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 24 months after MRLinac treatment
Secondary outcomes (16)
Regional control
Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 3 months after MRLinac treatment
Regional control
Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 6 months after MRLinac treatment
Regional control
Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 12 months after MRLinac treatment
Regional control
Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 24 months after MRLinac treatment
Distant failure
Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
Measured: 3 months after MRLinac treatment
Distant failure
Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
Measured: 12 months after MRLinac treatment
Distant failure
Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
Measured: 24 months after MRLinac treatment
Gastrointestinal toxicity
Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 3 months after MRLinac treatment
Gastrointestinal toxicity
Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 6 months after MRLinac treatment
Gastrointestinal toxicity
Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 24 months after MRLinac treatment
Urogenital toxicity
Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 3 months after MRLinac treatment
Urogenital toxicity
Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 6 months after MRLinac treatment
Urogenital toxicity
Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 24 months after MRLinac treatment
Vaginal toxicity
Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 3 months after MRLinac treatment
Vaginal toxicity
Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 6 months after MRLinac treatment
Vaginal toxicity
Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305)
Measured: 24 months after MRLinac treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Astrid van Lier, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937958
- Acronym
- MARGARITA
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: N/A yet
Publications
Edwards L, Tan H, Rahim K, Leong E, Carrillo-Serrano M, Liang T, Byrne HL, De Leon J, Sia S, Chee R. 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 Sep 12. doi: 10.1111/1754-9485.70185. Online ahead of print.
PubMed 42730749
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
- ClinicalTrials.gov ID
- NCT05937958
- Acronym / sponsor ID
- MARGARITA
- Conditions
- Cervical Cancer, Gynecologic Cancer
- Keywords
- Radiotherapy, MRLinac, Gynecologic Cancer, Local control, Toxicity, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standard treatment of locally advanced cervical cancer is chemoradiotherapy (external beam radiotherapy (EBRT) and concomitant chemotherapy with weekly Cisplatin) followed by image guided brachytherapy (IGBT). Recently, the MR Linac has emerged as new option for delivering an external beam radiotherapy boost to the primary cervical tumour after (chemo)radiaton in case brachytherapy is not feasible. MR Linac in these cases can replace traditional EBRT boosts and allow for better visualisation of the anatomy, smaller treatment margins and online treatment planning adaptation. This comes with potential for higher dose to the target and less dose to the surrounding organs.
Like in IGBT, an MRL treatment provides the possibility to perform repetitive imaging before and even during each fraction and allows for dose adaptation to anatomical changes in individual patients. This way not not only the daily position of OARs in relation to the target can be taken into account, but also possible tumor regression which often is obtained during chemoradiation. Based on the experience collected so far, the MRL treatment may be an interesting treatment option in selected cases as daily MRI and plan adaptation leads to more confined dose distribution compared to CBCT-Linac options. However, dose levels for the MRL-boost are likely to be lower than for IGBT, therefore its effectiveness is still unsure.
Aims of the study:
- To introduce MRL-boost in locally advanced cervical cancer in a multicenter setting within the frame of a prospective observational study.
- To establish a bench-mark for clinical outcome with MRL-boost in a multi-center patient population with respect to local control, survival and toxicity.
- To establish reference material with regard to MRL-based DVH parameters; if applicable delineations according to the guidelines from the GEC-ESTRO gynecology working group will be used.
- To report image-based DVH parameters for target (GTV, CTV, PTV) and for OARs
- To report recurrence patterns
- To report Quality of Life
Type of design
This study is a multicenter prospective observational study. Patient registration and dosimetric reporting will be performed in the individual centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Hard contra-indication for MRI scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local control
Time frame: 3 months after MRLinac treatment
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Local control
Time frame: 6 months after MRLinac treatment
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Local control
Time frame: 12 months after MRLinac treatment
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Local control
Time frame: 24 months after MRLinac treatment
Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
16 secondary outcomes
Regional control
Time frame: 3 months after MRLinac treatment
Regional control
Time frame: 6 months after MRLinac treatment
Regional control
Time frame: 12 months after MRLinac treatment
Regional control
Time frame: 24 months after MRLinac treatment
Distant failure
Time frame: 3 months after MRLinac treatment
Distant failure
Time frame: 12 months after MRLinac treatment
Distant failure
Time frame: 24 months after MRLinac treatment
Gastrointestinal toxicity
Time frame: 3 months after MRLinac treatment
Gastrointestinal toxicity
Time frame: 6 months after MRLinac treatment
Gastrointestinal toxicity
Time frame: 24 months after MRLinac treatment
Urogenital toxicity
Time frame: 3 months after MRLinac treatment
Urogenital toxicity
Time frame: 6 months after MRLinac treatment
Urogenital toxicity
Time frame: 24 months after MRLinac treatment
Vaginal toxicity
Time frame: 3 months after MRLinac treatment
Vaginal toxicity
Time frame: 6 months after MRLinac treatment
Vaginal toxicity
Time frame: 24 months after MRLinac treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 42730749Edwards L, Tan H, Rahim K, Leong E, Carrillo-Serrano M, Liang T, Byrne HL, De Leon J, Sia S, Chee R. 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 Sep 12. doi: 10.1111/1754-9485.70185. Online ahead of print.
- Individual participant dataSharing planned: Undecided. N/A yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Gynecologic Cancer, run by UMC Utrecht at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact van Lier, PhD (+31 88 755 8800, a.l.h.m.w.vanlier@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 3 months after MRLinac treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.