[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555603":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":46,"collaborators":50,"id":63,"slug":10,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer",null,"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.",[13],"Other: Observational study (Non-interventional study)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Observational study (Non-interventional study)","This is an observational study.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Remi A. Nout, PhD","CONTACT","+31107041366","r.nout@erasmusmc.nl",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"René M. Vernhout, MSc","+31107041341","r.vernhout@erasmusmc.nl",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Erasmus MC","RECRUITING","Rotterdam","South Holland","3015 CD","Netherlands",{"type":38,"coordinates":39},"Point",[40,41],4.47917,51.9225,{"lat":41,"lon":40},[44,45],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Remi A. Nout","Prof. dr.",[51,53,55,57,59,61],{"name":52,"class":6},"Aarhus University Hospital",{"name":54,"class":6},"Amsterdam University Medical Center",{"name":56,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris",{"name":58,"class":6},"Pitié-Salpêtrière Hospital",{"name":60,"class":6},"Leiden University Medical Center",{"name":62,"class":6},"Medical University of Vienna","100555603",false,"NCT06514235","Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)","EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr","EMBRAVE","Inclusion Criteria:\n\no Histologically proven primary vaginal cancer, vaginal carcinoma in situ (VAIN) or vaginal recurrence, per WHO classification.\n\nHistological 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\n\n* 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.\n* Para-aortic lymph node metastasis below L1-L2 interspace are allowed\n* Macroscopic visible tumour present on MRI and\u002For gynaecological examination at diagnosis.\n* Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed):\n\n  * External beam radio(chemo)therapy followed by IGABT\n  * IGABT alone for stage I \\\u003C2cm or carcinoma in situ\n* Treatment with curative intent\n* Written informed consent\n\nExclusion Criteria:\n\n* Primary vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)\n* Metastatic disease beyond para-aortic region L1-L2 interspace\n* Sarcomas and melanomas.\n* Treatment only by external beam radiotherapy without brachytherapy to boost the primary disease\n* Primary vaginal cancer: treatment by primary surgery or debulking surgery\n* Vaginal recurrences: treatment by primary surgery or debulking surgery\n* Treatment with neo-adjuvant chemotherapy followed by surgery\n* Treatment with radiotherapy followed by surgery\n* Previous pelvic or abdominal radiotherapy\n* Pregnancy","FEMALE","18 Years",{"count":73,"type":74},300,"ESTIMATED","OBSERVATIONAL","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).\n\nBeing an observational, prospective registration study, wherein neither an experimental treatment is compared to the standard treatment, nor groups of patients are compared.\n\nThe specific aims are:\n\n* to develop evidence-based recommendations for curative intent treatment with primary radio(chemo)therapy and IGABT.\n* to identify prognostic parameters for oncological outcomes, morbidity and quality of life.\n\nThe 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.",[78],"Vaginal Neoplasms","2025-08-14",{"date":81,"type":82},"2025-08-19","ACTUAL",{"date":84,"type":82},"2022-11-28",{"date":86,"type":74},"2033-11-30",{"name":5,"class":6},1]