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NCT Number: NCT06514235

Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

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.

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Key information

Conditions

Vaginal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vaginal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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):
  • 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

Exclusion criteria

  • 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
  • Treatment with neo-adjuvant chemotherapy followed by surgery
  • Treatment with radiotherapy followed by surgery
  • Previous pelvic or abdominal radiotherapy
  • Pregnancy

Treatment and study plan

Observational study (Non-interventional study)

Other

This is an observational study.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Other oncological outcomes

    Time frame: 2 and 5 years of follow-up

    Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.

Study contacts

Contact information is provided by the study sponsor or research team.

Remi A. Nout, PhD

CONTACT

[email protected]

+31107041366

René M. Vernhout, MSc

CONTACT

[email protected]

+31107041341

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Aarhus University Hospital
  • Amsterdam University Medical Center
  • Gustave Roussy, Cancer Campus, Grand Paris
  • Leiden University Medical Center
  • Medical University of Vienna
  • Pitié-Salpêtrière Hospital

Registry information

Official study title

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

Acronym: EMBRAVE

Important dates

Study start
2022
Primary completion
2033
Study completion
2033
First posted
Jul 23, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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