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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05937958
Registration number
NCT05937958
Ethics application status
Date submitted
30/06/2023
Date registered
10/07/2023
Date last updated
18/07/2023
Titles & IDs
Public title
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible (MARGARITA)
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Scientific title
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
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Universal Trial Number (UTN)
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Trial acronym
MARGARITA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer
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Gynecologic Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Local control
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Assessment method [1]
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Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [1]
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3 months after MRLinac treatment
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Primary outcome [2]
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Local control
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Assessment method [2]
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Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [2]
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6 months after MRLinac treatment
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Primary outcome [3]
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Local control
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Assessment method [3]
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Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [3]
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12 months after MRLinac treatment
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Primary outcome [4]
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Local control
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Assessment method [4]
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Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [4]
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24 months after MRLinac treatment
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Secondary outcome [1]
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Regional control
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Assessment method [1]
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Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [1]
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0
3 months after MRLinac treatment
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Secondary outcome [2]
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0
Regional control
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Assessment method [2]
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Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [2]
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0
6 months after MRLinac treatment
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Secondary outcome [3]
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0
Regional control
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Assessment method [3]
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Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [3]
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0
12 months after MRLinac treatment
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Secondary outcome [4]
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Regional control
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Assessment method [4]
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Regional control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
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Timepoint [4]
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24 months after MRLinac treatment
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Secondary outcome [5]
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0
Distant failure
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Assessment method [5]
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Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
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Timepoint [5]
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3 months after MRLinac treatment
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Secondary outcome [6]
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Distant failure
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Assessment method [6]
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Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
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Timepoint [6]
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12 months after MRLinac treatment
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Secondary outcome [7]
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Distant failure
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Assessment method [7]
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Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care
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Timepoint [7]
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24 months after MRLinac treatment
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Secondary outcome [8]
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0
Gastrointestinal toxicity
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Assessment method [8]
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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)
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Timepoint [8]
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0
3 months after MRLinac treatment
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Secondary outcome [9]
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0
Gastrointestinal toxicity
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Assessment method [9]
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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)
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Timepoint [9]
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0
6 months after MRLinac treatment
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Secondary outcome [10]
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0
Gastrointestinal toxicity
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Assessment method [10]
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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)
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Timepoint [10]
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0
24 months after MRLinac treatment
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Secondary outcome [11]
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Urogenital toxicity
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Assessment method [11]
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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)
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Timepoint [11]
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0
3 months after MRLinac treatment
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Secondary outcome [12]
0
0
Urogenital toxicity
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Assessment method [12]
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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)
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Timepoint [12]
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6 months after MRLinac treatment
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Secondary outcome [13]
0
0
Urogenital toxicity
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Assessment method [13]
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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)
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Timepoint [13]
0
0
24 months after MRLinac treatment
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Secondary outcome [14]
0
0
Vaginal toxicity
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Assessment method [14]
0
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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)
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Timepoint [14]
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3 months after MRLinac treatment
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Secondary outcome [15]
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0
Vaginal toxicity
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Assessment method [15]
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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)
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Timepoint [15]
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6 months after MRLinac treatment
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Secondary outcome [16]
0
0
Vaginal toxicity
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Assessment method [16]
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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)
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Timepoint [16]
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24 months after MRLinac treatment
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Hard contra-indication for MRI scanning
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2027
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Odense
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Country [2]
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Netherlands
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State/province [2]
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Utrecht
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Funding & Sponsors
Primary sponsor type
Other
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Name
UMC Utrecht
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Odense University Hospital
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05937958
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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van Lier, PhD
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Address
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Country
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Phone
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+31 88 755 8800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05937958
Download to PDF