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. 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.
∙ 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