[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-cancer-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-cancer-stage-i":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100552711","phase-3-a-phase-iii-randomised-clinical-trial-of-ultrasound-groin-monitoring-versus-groin-lymph-node-dissection-to-de-escalate-the-extent-of-surgery-in-vulvar-cancer-100552711",false,"NCT06476639","A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer","ANVU","Inclusion Criteria:\n\n* Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva\n* Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease\n* Willing and able to undergo IFL\u002FSNB according to local clinical practice management guidelines\n* Willing and able to comply with all study requirements, timing and\u002For nature of required assessments.\n* Signed written informed consent\n* Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)\n* Clinical or medical imaging evidence of regional and\u002For distant metastatic disease\n* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n* Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ\n* Estimated life expectancy of ≤6 months","FEMALE","18 Years",{"count":19,"type":20},640,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.",[26,27,28,29,30],"Vulvar Cancer Stage I","Vulvar Cancer Stage II","Lymph Node Metastasis","Groin Node","Ultrasound Therapy; Complications",[32,33],"Vulvar Cancer","Ultrasound Therapy","NOT_YET_RECRUITING","2026-03-19",{"date":37,"type":38},"2026-03-24","ACTUAL",{"date":40,"type":20},"2026-06-01",{"date":42,"type":20},"2035-12-31",{"name":44,"class":45},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",9]