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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study (Non-interventional study)
Other interventionThis is an observational study.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer1 intervention
Trial outcomes
Primary outcomes
1
Local failure
A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).
Time frame
2 and 5 years of follow-up2
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).
Time frame
2 and 5 years of follow-up3
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).
Time frame
End of TreatmentSecondary outcomes
1
Other oncological outcomes
Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.
Time frame
2 and 5 years of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
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