[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445169":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":37,"responsibleParty":370,"collaborators":373,"id":378,"slug":27,"hasResults":379,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":379,"sex":385,"minAge":386,"maxAge":27,"enrollmentInfo":387,"targetDuration":27,"studyType":390,"phases":391,"briefSummary":393,"conditions":394,"keywords":27,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemoradiation","EXPERIMENTAL","Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg\u002Fm2 intravenously on days 1, 8, 15, 22 and 29",[13,14],"Radiation: Radiotherapy combined with cisplatin","Drug: Cisplatin",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Radiotherapy combined with cisplatin","Inguinofemoral radiotherapy combined with weekly cisplatin",[9],[22],"chemotherapy",{"type":24,"name":25,"description":19,"armGroupLabels":26,"otherNames":27},"DRUG","Cisplatin",[9],null,[29,34],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Maaike H Oonk, MD PhD","CONTACT","+31-50-3613000","m.h.m.oonk@umcg.nl",{"name":35,"role":31,"phone":27,"phoneExt":27,"email":36},"Liza Lahaye","eventinbox@umcg.nl",[38,55,68,81,94,105,118,131,144,155,166,178,189,199,210,223,235,248,260,273,286,299,312,322,334,346,358],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"UC Irvine Health\u002FChao Family Comprehensive Cancer Center","RECRUITING","Orange","California","92868","United States",{"type":46,"coordinates":47},"Point",[48,49],-117.85311,33.78779,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":27,"phoneExt":27,"email":27},"Krishnansu Tewari","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":40,"city":57,"state":58,"zip":59,"country":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Mount Sinai Medical Center","Miami Beach","Florida","33140",{"type":46,"coordinates":61},[62,63],-80.13005,25.79065,{"lat":63,"lon":62},[66],{"name":67,"role":54,"phone":27,"phoneExt":27,"email":27},"Brian Slomovitz",{"facility":69,"status":40,"city":70,"state":71,"zip":72,"country":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Baystate Medical Center","Springfield","Massachusetts","01199",{"type":46,"coordinates":74},[75,76],-72.58981,42.10148,{"lat":76,"lon":75},[79],{"name":80,"role":54,"phone":27,"phoneExt":27,"email":27},"Tashanna Myers",{"facility":82,"status":40,"city":83,"state":84,"zip":85,"country":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Spectrum Health at Butterworth Campus","Grand Rapids","Michigan","49503",{"type":46,"coordinates":87},[88,89],-85.66809,42.96336,{"lat":89,"lon":88},[92],{"name":93,"role":54,"phone":27,"phoneExt":27,"email":27},"Kathleen Yost",{"facility":95,"status":40,"city":96,"state":84,"zip":97,"country":44,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Munson Medical Center","Traverse City","49684",{"type":46,"coordinates":99},[100,101],-85.62063,44.76306,{"lat":101,"lon":100},[104],{"name":93,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":106,"status":40,"city":107,"state":108,"zip":109,"country":44,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Nebraska Methodist Hospital","Omaha","Nebraska","68114",{"type":46,"coordinates":111},[112,113],-95.94043,41.25626,{"lat":113,"lon":112},[116],{"name":117,"role":54,"phone":27,"phoneExt":27,"email":27},"Brent Tierney",{"facility":119,"status":40,"city":120,"state":121,"zip":122,"country":44,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Women's Cancer Center of Nevada","Las Vegas","Nevada","89106",{"type":46,"coordinates":124},[125,126],-115.13722,36.17497,{"lat":126,"lon":125},[129],{"name":130,"role":54,"phone":27,"phoneExt":27,"email":27},"Nicola Spirtos",{"facility":132,"status":40,"city":133,"state":134,"zip":135,"country":44,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Memorial Sloan Kettering Basking Ridge","Basking Ridge","New Jersey","07920",{"type":46,"coordinates":137},[138,139],-74.54932,40.70621,{"lat":139,"lon":138},[142],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},"Mario Leitao",{"facility":145,"status":40,"city":146,"state":134,"zip":147,"country":44,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Memorial Sloan Kettering Monmouth","Middletown","07748",{"type":46,"coordinates":149},[150,151],-74.11709,40.39428,{"lat":151,"lon":150},[154],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":156,"status":40,"city":157,"state":134,"zip":158,"country":44,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Memorial Sloan Kettering Bergen","Montvale","07645",{"type":46,"coordinates":160},[161,162],-74.02292,41.04676,{"lat":162,"lon":161},[165],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":167,"status":40,"city":168,"state":169,"zip":170,"country":44,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Memorial Sloan Kettering Commack","Commack","New York","11725",{"type":46,"coordinates":172},[173,174],-73.29289,40.84288,{"lat":174,"lon":173},[177],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":179,"status":40,"city":180,"state":169,"zip":181,"country":44,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Memorial Sloan Kettering Westchester","Harrison","10604",{"type":46,"coordinates":183},[184,185],-73.71263,40.96899,{"lat":185,"lon":184},[188],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":190,"status":40,"city":169,"state":169,"zip":191,"country":44,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Memorial Sloan Kettering Cancer Center","10065",{"type":46,"coordinates":193},[194,195],-74.00597,40.71427,{"lat":195,"lon":194},[198],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":200,"status":40,"city":201,"state":169,"zip":202,"country":44,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Memorial Sloan Kettering Nassau","Uniondale","11553",{"type":46,"coordinates":204},[205,206],-73.59291,40.70038,{"lat":206,"lon":205},[209],{"name":143,"role":54,"phone":27,"phoneExt":27,"email":27},{"facility":211,"status":40,"city":212,"state":213,"zip":214,"country":44,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Duke University Medical Center","Durham","North Carolina","27710",{"type":46,"coordinates":216},[217,218],-78.89862,35.99403,{"lat":218,"lon":217},[221],{"name":222,"role":54,"phone":27,"phoneExt":27,"email":27},"Diandra Ayala-Peacock",{"facility":224,"status":40,"city":225,"state":213,"zip":226,"country":44,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Duke Women's Cancer Care Raleigh","Raleigh","27607",{"type":46,"coordinates":228},[229,230],-78.63861,35.7721,{"lat":230,"lon":229},[233],{"name":234,"role":54,"phone":27,"phoneExt":27,"email":27},"Daindra Ayala-Peacock",{"facility":236,"status":40,"city":237,"state":238,"zip":239,"country":44,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":46,"coordinates":241},[242,243],-82.99879,39.96118,{"lat":243,"lon":242},[246],{"name":247,"role":54,"phone":27,"phoneExt":27,"email":27},"Christa Nagel",{"facility":249,"status":40,"city":250,"state":238,"zip":251,"country":44,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"ProMedica Flower Hospital","Sylvania","43560",{"type":46,"coordinates":253},[254,255],-83.71299,41.71894,{"lat":255,"lon":254},[258],{"name":259,"role":54,"phone":27,"phoneExt":27,"email":27},"Adam Walter",{"facility":261,"status":40,"city":262,"state":263,"zip":264,"country":44,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":46,"coordinates":266},[267,268],-97.51643,35.46756,{"lat":268,"lon":267},[271],{"name":272,"role":54,"phone":27,"phoneExt":27,"email":27},"Laura Holman",{"facility":274,"status":40,"city":275,"state":276,"zip":277,"country":44,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Women and Infants Hospital","Providence","Rhode Island","02905",{"type":46,"coordinates":279},[280,281],-71.41283,41.82399,{"lat":281,"lon":280},[284],{"name":285,"role":54,"phone":27,"phoneExt":27,"email":27},"Paul DiSilvestro",{"facility":287,"status":40,"city":288,"state":289,"zip":290,"country":44,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Avera Cancer Institute","Sioux Falls","South Dakota","57105",{"type":46,"coordinates":292},[293,294],-96.72796,43.54369,{"lat":294,"lon":293},[297],{"name":298,"role":54,"phone":27,"phoneExt":27,"email":27},"David Starks",{"facility":300,"status":40,"city":301,"state":27,"zip":302,"country":303,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Catharina Hospital Eindhoven","Eindhoven","5623EJ","Netherlands",{"type":46,"coordinates":305},[306,307],5.47778,51.44083,{"lat":307,"lon":306},[310],{"name":311,"role":54,"phone":27,"phoneExt":27,"email":27},"Dorry Boll",{"facility":5,"status":40,"city":313,"state":27,"zip":314,"country":303,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Groningen","9712RB",{"type":46,"coordinates":316},[317,318],6.56667,53.21917,{"lat":318,"lon":317},[321],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},{"facility":323,"status":40,"city":324,"state":27,"zip":325,"country":303,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Leiden University Medical Center","Leiden","2333ZA",{"type":46,"coordinates":327},[328,329],4.49306,52.15833,{"lat":329,"lon":328},[332],{"name":333,"role":54,"phone":27,"phoneExt":27,"email":27},"Mariette van Poelgeest",{"facility":335,"status":40,"city":336,"state":27,"zip":337,"country":303,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"Radboud University Medical Center","Nijmegen","6525GA",{"type":46,"coordinates":339},[340,341],5.85278,51.8425,{"lat":341,"lon":340},[344],{"name":345,"role":54,"phone":27,"phoneExt":27,"email":27},"Joanne de Hullua",{"facility":347,"status":40,"city":348,"state":27,"zip":349,"country":303,"cosmosGeoPoint":350,"geoPoint":354,"contacts":355},"Erasmus Medical Center","Rotterdam","3015GD",{"type":46,"coordinates":351},[352,353],4.47917,51.9225,{"lat":353,"lon":352},[356],{"name":357,"role":54,"phone":27,"phoneExt":27,"email":27},"Lena van Doorn",{"facility":359,"status":40,"city":360,"state":27,"zip":361,"country":303,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"University Medical Center Utrecht","Utrecht","3584CX",{"type":46,"coordinates":363},[364,365],5.12222,52.09083,{"lat":365,"lon":364},[368],{"name":369,"role":54,"phone":27,"phoneExt":27,"email":27},"Eleonora van Dorst",{"type":54,"investigatorFullName":371,"investigatorTitle":372,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Maaike Oonk","Principle Investigator",[374,376],{"name":375,"class":6},"Dutch Cancer Society",{"name":377,"class":6},"NRG Oncology","100445169",false,"NCT05076942","Groningen International Study on Sentinel Nodes in Vulvar Cancer-III","Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial","GROINSS-VIII","Inclusion Criteria:\n\n* Histological confirmed primary SCC of the vulva\n* T1 tumor, not encroaching urethra\u002Fvagina\u002Fanus\n* Depth of invasion \\> 1mm\n* Tumor diameter \\\u003C 4cm\n* Unifocal tumor\n* No enlarged (\\>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT\u002FMRI\u002Fultrasound)\n* Possibility to obtain informed consent\n* Metastatic sentinel lymph node; size of metastasis \\> 2mm and \u002F or extracapsular extension, or\n* Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm\n* Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures\n* Adequate bone marrow, renal and liver function:\n\n  * Absolute neutrophil count ≥ 1.5 x 109 \u002FL\n  * Platelet count ≥ 100 x 109 \u002FL\n  * Creatinine clearance ≥ 40 ml\u002Fmin measured by the Cockroft Gault formula\n  * Total bilirubin \\\u003C 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN\n* Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)\n* Age 18 years or older\n* Life expectancy of ≥ 12 weeks\n* Written informed consent\n\nExclusion Criteria:\n\n* Inoperable tumors and tumors \\> 4cm\n* Multifocal tumors\n* Tumors with other pathology than squamous cell carcinoma\n* Patients with enlarged \u002F suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology\n* No other carcinomas, other than basal cell carcinomas, within last 5 years\n* History of pelvic radiotherapy\n* History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment\n* Pregnant female or nursing mother\n* Desire to become pregnant\n* Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids\n* Unstable angina, myocardial infarction, cerebrovascular accident, \\> Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment","FEMALE","18 Years",{"count":388,"type":389},157,"ESTIMATED","INTERVENTIONAL",[392],"PHASE2","Vulvar cancer patients with SN-metastasis \\> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.",[395,396,397],"Vulvar Cancer","Sentinel Lymph Node","Lymph Node Metastases","2023-07-27",{"date":400,"type":401},"2023-08-01","ACTUAL",{"date":403,"type":401},"2021-01-01",{"date":405,"type":389},"2029-01-01",{"name":5,"class":6},27]