Vaginal NeoplasmsEMBRAVENCT06514235
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
An observational study of Vaginal Neoplasms, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Neoplasms
- What is being tested?
- Observational study (Non-interventional study)
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Nov 2022to 30 Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- o Histologically proven primary vaginal cancer, vaginal carcinoma in situ (VAIN) or vaginal recurrence, per WHO classification.
- Histological proven stage I-IVA primary vaginal cancer: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina, other epithelial carcinoma's and carcinoma in situ
- Histological proven vaginal recurrence from any gynaecological cancer for whom curative treatment is envisioned that includes image guided adaptive brachytherapy according to the target concept.
- Para-aortic lymph node metastasis below L1-L2 interspace are allowed
- Macroscopic visible tumour present on MRI and/or gynaecological examination at diagnosis.
- Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed):
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- External beam radio(chemo)therapy followed by IGABT
- IGABT alone for stage I <2cm or carcinoma in situ
- Treatment with curative intent
- Written informed consent
Who cannot join
- Primary vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)
- Metastatic disease beyond para-aortic region L1-L2 interspace
- Sarcomas and melanomas.
- Treatment only by external beam radiotherapy without brachytherapy to boost the primary disease
- Primary vaginal cancer: treatment by primary surgery or debulking surgery
- Vaginal recurrences: treatment by primary surgery or debulking surgery
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- Treatment with neo-adjuvant chemotherapy followed by surgery
- Treatment with radiotherapy followed by surgery
- Previous pelvic or abdominal radiotherapy
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CD
Remi A. Nout, PhD, +31107041366, r.nout@erasmusmc.nl
René M. Vernhout, MSc, +31107041341, r.vernhout@erasmusmc.nl
About this study
Official title: EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
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.
Read more
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
- Being tested
- Observational study (Non-interventional study)
- Medical subject headings
- Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study (Non-interventional study)Other
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer | 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. Receives: Other: Observational study (Non-interventional study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure
A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).
Measured: 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).
Measured: 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).
Measured: End of Treatment
Secondary outcomes (1)
Other oncological outcomes
Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.
Measured: 2 and 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start28 Nov 2022
- Primary completion30 Nov 2033 (estimated)
- Study completion30 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Amsterdam University Medical Center, Gustave Roussy, Cancer Campus, Grand Paris, Pitié-Salpêtrière Hospital, Leiden University Medical Center, Medical University of Vienna
- Responsible party
- Principal investigator, Prof. Dr. Remi A. Nout, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514235
- Sponsor's protocol ID
- MEC-2021-0820
- Other IDs
- PaNaMa ID 6517
- Acronym
- EMBRAVE
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
- ClinicalTrials.gov ID
- NCT06514235
- Acronym / sponsor ID
- EMBRAVE / MEC-2021-0820
- Conditions
- Vaginal Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Amsterdam University Medical Center, Gustave Roussy, Cancer Campus, Grand Paris, Pitié-Salpêtrière Hospital, Leiden University Medical Center, Medical University of Vienna
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Nov 2033 (estimated)
- Study completion
- 30 Nov 2033 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer | – | Other: Observational study (Non-interventional study)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- o Histologically proven primary vaginal cancer, vaginal carcinoma in situ (VAIN) or vaginal recurrence, per WHO classification.
- Histological proven stage I-IVA primary vaginal cancer: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina, other epithelial carcinoma's and carcinoma in situ
- Histological proven vaginal recurrence from any gynaecological cancer for whom curative treatment is envisioned that includes image guided adaptive brachytherapy according to the target concept.
- Para-aortic lymph node metastasis below L1-L2 interspace are allowed
- Macroscopic visible tumour present on MRI and/or gynaecological examination at diagnosis.
Key exclusion criteria (10 listed)
- Primary vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)
- Metastatic disease beyond para-aortic region L1-L2 interspace
- Sarcomas and melanomas.
- Treatment only by external beam radiotherapy without brachytherapy to boost the primary disease
- Primary vaginal cancer: treatment by primary surgery or debulking surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study (Non-interventional study)This is an observational study. | Other | Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer |
Primary outcome
Local failure
Time frame: 2 and 5 years of follow-up
A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).
Late physician-assessed morbidity and patient reported outcomes
Time frame: 2 and 5 years of follow-up
Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
Acute physician-assessed morbidity and patient reported outcomes
Time frame: End of Treatment
Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
1 secondary outcome
Other oncological outcomes
Time frame: 2 and 5 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Neoplasms, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remi A. Nout, PhD (+31107041366, r.nout@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local failure (time frame: 2 and 5 years of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.