Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
ConditionVaginal Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
External beam radio(chemo)therapy followed by IGABT
Disqualifiers
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
Trial design
Treatments tested in this trial
- Observational study (Non-interventional study)
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Aarhus University Hospital
Collaborator
Amsterdam University Medical Center
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Pitié-Salpêtrière Hospital
Collaborator
Leiden University Medical Center
Collaborator
Medical University of Vienna
Collaborator
Source ClinicalTrials.gov