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Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

NCT06514235 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-19

No results posted yet for this study

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

OTHER

Observational study (Non-interventional study)

This is an observational study.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Amsterdam University Medical Center

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Medical University of Vienna

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2033-11-30
Completion
2033-11-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514235 on ClinicalTrials.gov