NCT06514235

Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * to develop evidence-based recommendations for curative intent treatment with primary radio(chemo)therapy and IGABT. * to identify prognostic parameters for oncological outcomes, morbidity and quality of life. The study aims to enroll at least 300 patients. Oncological events will be evaluated at 2 and 5 years of follow-up. Acute and late morbidity events will be evaluated at end of treatment, 2 and 5 years of follow-up.

Conditions

• Vaginal Neoplasms

Interventions

Type	Name	Description
OTHER	Observational study (Non-interventional study)	This is an observational study.

Timeline

• Start date: 2022-11-28
• Primary completion: 2033-11-30
• Completion: 2033-11-30
• First posted: 2024-07-23
• Last updated: 2025-08-19

Locations

1 site across 1 country: Netherlands