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RECRUITING
NCT06514235

Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2022-11-28

Completion Date

2033-11-30

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

OTHER

Observational study (Non-interventional study)

This is an observational study.

Locations (1)

Erasmus MC

Rotterdam, South Holland, Netherlands