NCT06514235|Recruiting
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
EMBRAVE
EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
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EMBRAVE
EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
Sponsor study identifier
Secondary identifiers
OTHER · ErasmusMC
observational
300
1 country
1
Study Start
November 28, 2022
Actual (reported)Primary Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer including vaginal recurrences who are treated with curative intent by primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT). Being an observational, prospective registration study, wherein neither an experimental treatment is compared to the standard treatment, nor groups of patients are compared. The specific aims are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2022
Actual (reported)July 4, 2024
Actual (reported)July 23, 2024
Actual (reported)November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Local failure
A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).
2 and 5 years of follow-up
Late physician-assessed morbidity and patient reported outcomes
Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
2 and 5 years of follow-up
Acute physician-assessed morbidity and patient reported outcomes
Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
End of Treatment
Other oncological outcomes
2 and 5 years of follow-up
Adult patients with vaginal cancer treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy according to the protocol target concept.
This is an observational study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients with primary vaginal cancer stage I-IVA or vaginal recurrence from any gynaecologial cancer who are treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy.
Erasmus MC
Rotterdam, South Holland, 3015 CD, Netherlands
First Submitted
July 4, 2024
First Posted
July 23, 2024
Study Start
November 28, 2022
Actual (reported)Primary Completion
November 30, 2033
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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