Actively Recruiting
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
Led by Erasmus Medical Center · Updated on 2025-08-19
300
Participants Needed
1
Research Sites
574 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary vaginal cancer, vaginal carcinoma in situ (VAIN), or vaginal recurrence by WHO classification
- Stage I-IVA primary vaginal cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, other epithelial carcinomas, and carcinoma in situ
- Histologically confirmed vaginal recurrence from any gynecological cancer with planned curative treatment including image guided adaptive brachytherapy
- Para-aortic lymph node metastasis allowed if below L1-L2 interspace
- Visible tumor on MRI or gynecological exam at diagnosis
- Planned MRI-guided adaptive brachytherapy treatment with at least the first fraction contoured and planned on MRI; CT allowed for later fractions
- External beam radio(chemo)therapy followed by IGABT or IGABT alone for stage I <2cm or carcinoma in situ
- Treatment intended to cure the cancer
- Provided written informed consent
You will not qualify if you...
- Vaginal cancers involving cervix ostium or vulva
- Metastatic disease beyond para-aortic lymph node at L1-L2 interspace
- Sarcomas and melanomas
- Treatment using only external beam radiotherapy without brachytherapy boost
- Primary vaginal cancer treated by surgery or debulking surgery
- Vaginal recurrences treated by surgery or debulking surgery
- Treatment with neo-adjuvant chemotherapy followed by surgery
- Treatment with radiotherapy followed by surgery
- Previous pelvic or abdominal radiotherapy
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CD
Actively Recruiting
Research Team
R
Remi A. Nout, PhD
CONTACT
R
René M. Vernhout, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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