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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05937958




Registration number
NCT05937958
Ethics application status
Date submitted
30/06/2023
Date registered
10/07/2023

Titles & IDs
Public title
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
Scientific title
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
Universal Trial Number (UTN)
Trial acronym
MARGARITA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Gynecologic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local control
Timepoint [1] 0 0
3 months after MRLinac treatment
Primary outcome [2] 0 0
Local control
Timepoint [2] 0 0
6 months after MRLinac treatment
Primary outcome [3] 0 0
Local control
Timepoint [3] 0 0
12 months after MRLinac treatment
Primary outcome [4] 0 0
Local control
Timepoint [4] 0 0
24 months after MRLinac treatment
Secondary outcome [1] 0 0
Regional control
Timepoint [1] 0 0
3 months after MRLinac treatment
Secondary outcome [2] 0 0
Regional control
Timepoint [2] 0 0
6 months after MRLinac treatment
Secondary outcome [3] 0 0
Regional control
Timepoint [3] 0 0
12 months after MRLinac treatment
Secondary outcome [4] 0 0
Regional control
Timepoint [4] 0 0
24 months after MRLinac treatment
Secondary outcome [5] 0 0
Distant failure
Timepoint [5] 0 0
3 months after MRLinac treatment
Secondary outcome [6] 0 0
Distant failure
Timepoint [6] 0 0
12 months after MRLinac treatment
Secondary outcome [7] 0 0
Distant failure
Timepoint [7] 0 0
24 months after MRLinac treatment
Secondary outcome [8] 0 0
Gastrointestinal toxicity
Timepoint [8] 0 0
3 months after MRLinac treatment
Secondary outcome [9] 0 0
Gastrointestinal toxicity
Timepoint [9] 0 0
6 months after MRLinac treatment
Secondary outcome [10] 0 0
Gastrointestinal toxicity
Timepoint [10] 0 0
24 months after MRLinac treatment
Secondary outcome [11] 0 0
Urogenital toxicity
Timepoint [11] 0 0
3 months after MRLinac treatment
Secondary outcome [12] 0 0
Urogenital toxicity
Timepoint [12] 0 0
6 months after MRLinac treatment
Secondary outcome [13] 0 0
Urogenital toxicity
Timepoint [13] 0 0
24 months after MRLinac treatment
Secondary outcome [14] 0 0
Vaginal toxicity
Timepoint [14] 0 0
3 months after MRLinac treatment
Secondary outcome [15] 0 0
Vaginal toxicity
Timepoint [15] 0 0
6 months after MRLinac treatment
Secondary outcome [16] 0 0
Vaginal toxicity
Timepoint [16] 0 0
24 months after MRLinac treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hard contra-indication for MRI scanning

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Odense
Country [2] 0 0
Netherlands
State/province [2] 0 0
Utrecht

Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Odense University Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
van Lier, PhD
Address 0 0
Country 0 0
Phone 0 0
+31 88 755 8800
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05937958