[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100232591":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":69,"centralContacts":77,"locations":86,"responsibleParty":289,"collaborators":291,"id":298,"slug":299,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":300,"sex":305,"minAge":306,"maxAge":36,"enrollmentInfo":307,"targetDuration":36,"studyType":310,"phases":311,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":89,"whyStopped":36,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",[8,14,22,27,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Standard Surgery (ILND)","ACTIVE_COMPARATOR","Part of randomisation 1.\n\nThe total treatment duration (Inguinal Lymph Node Dissection (ILND)) is estimated to be over 1 day for those patients allocated to Arm A - standard surgery.",[13],"Procedure: ILND - Inguinal Lymph Node Dissection",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B - neoadjuvant chemotherapy","EXPERIMENTAL","Part of randomisation 1.\n\nPatients will receive up to 4 cycles of Paclitaxel, Ifosfamide, and Cisplatin (TIP).\n\nAdministration on an outpatient basis:\n\nPaclitaxel 175 mg\u002Fm2, day 1, Ifosfamide 900 mg\u002Fm2, days 2-5, Cisplatin 15 mg\u002Fm2, days 1-5\n\nAdministration on an inpatient basis:\n\nPaclitaxel 175 mg\u002Fm2, day 1, Ifosfamide 1200 mg\u002Fm2, days 1-3, Cisplatin 25 mg\u002Fm2, days 1-3",[19,20,21],"Drug: Paclitaxel","Drug: Ifosfamide","Drug: Cisplatin",{"label":23,"type":16,"description":24,"interventionNames":25},"Arm C - neoadjuvant chemoradiotherapy","Part of randomisation 1.\n\nRadiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions.\n\nConcurrent cisplatin 40mg\u002Fm2 will be given weekly, subject to GFR\\>45mls\u002Fmin.",[21,26],"Radiation: Intensity modulated radiation treatment (IMRT)",{"label":28,"type":16,"description":29,"interventionNames":30},"Arm P - prophylactic PLND","Part of randomisation 2.\n\nProphylactic pelvic lymph node dissection (PLND) - The total treatment duration is estimated to be over 1 day.\n\nPatients who have NOT received neoadjuvant chemoradiotherapy will receive adjuvant chemoradiotherapy:\n\nCisplatin 40mg\u002Fm2 will be given weekly, subject to GFR\\>45mls\u002Fmin.\n\nGroin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour\n\nPelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to:\n\n1. Any macroscopic tumour or pathological lymph nodes\n2. Electively to external iliac nodes in patient with high disease burden\n\nPatients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.",[31],"Procedure: Prophylactic PLND - pelvic lymph node dissection",{"label":33,"type":34,"description":35,"interventionNames":36},"Arm Q - Surveillance no prophylactic PLND","NO_INTERVENTION","no prophylactic PLND Part of randomisation 2.\n\nFor patients who have NOT received neoadjuvant chemoradiotherapy:\n\nGroin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumour\n\nPelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to:\n\nAny macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden",null,[38,43,50,56,60,65],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":36},"PROCEDURE","ILND - Inguinal Lymph Node Dissection","Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.",[9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Paclitaxel","Dose 175mg\u002Fm2 as part of TIP regimen.",[15],[49],"Taxol",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Ifosfamide","Dose 900mg\u002Fm2 as part of TIP regimen.",[15],[55],"Mitoxana",{"type":44,"name":57,"description":58,"armGroupLabels":59,"otherNames":36},"Cisplatin","Dose 15mg\u002Fm2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg\u002Fm2 for use concurrently with raditotherapy (chemoradiotherapy arm)",[15,23],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":36},"RADIATION","Intensity modulated radiation treatment (IMRT)","Treatment with very high energy X-rays (radiotherapy).",[23],{"type":39,"name":66,"description":67,"armGroupLabels":68,"otherNames":36},"Prophylactic PLND - pelvic lymph node dissection","Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.",[28],[70,74],{"name":71,"affiliation":72,"role":73},"Steve Nicholson","Mid and South Essex NHS Foundation Trust","STUDY_CHAIR",{"name":75,"affiliation":76,"role":73},"Curtis Pettaway","University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":36,"email":82},"UK - InPACT Senior Trial Manager","CONTACT","02087224261","InPACT-icrctsu@icr.ac.uk",{"name":84,"role":80,"phone":85,"phoneExt":36,"email":36},"US\u002FCanada - InPACT DA for EA8134","(857)504-2900",[87,106,115,130,141,152,162,180,190,200,210,224,238,250,259,268,280],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Los Angeles County-USC Medical Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-118.24368,34.05223,{"lat":99,"lon":98},[102],{"name":103,"role":80,"phone":104,"phoneExt":36,"email":105},"Anne Schuckman","(323)865-3700","anne.schuckman@med.usc.edu",{"facility":107,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"USC \u002F Norris Comprehensive Cancer Center",{"type":96,"coordinates":109},[98,99],{"lat":99,"lon":98},[112],{"name":113,"role":80,"phone":104,"phoneExt":36,"email":114},"Sia Daneshmand","daneshma@usc.edu",{"facility":116,"status":89,"city":117,"state":118,"zip":119,"country":93,"countryCode":94,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":96,"coordinates":121},[122,123],-82.45843,27.94752,{"lat":123,"lon":122},[126],{"name":127,"role":80,"phone":128,"phoneExt":36,"email":129},"Phil Spiess","(813)745-8343","Philippe.spiess@moffitt.org",{"facility":131,"status":132,"city":133,"state":134,"zip":135,"country":93,"countryCode":94,"cosmosGeoPoint":136,"geoPoint":140,"contacts":36},"Grady Health System","ACTIVE_NOT_RECRUITING","Atlanta","Georgia","30303",{"type":96,"coordinates":137},[138,139],-84.38798,33.749,{"lat":139,"lon":138},{"facility":142,"status":89,"city":133,"state":134,"zip":143,"country":93,"countryCode":94,"cosmosGeoPoint":144,"geoPoint":146,"contacts":147},"Emory University Hospital\u002FWinship Cancer Institute","30322",{"type":96,"coordinates":145},[138,139],{"lat":139,"lon":138},[148],{"name":149,"role":80,"phone":150,"phoneExt":36,"email":151},"Viraj Master","(404)778-4898","vmaster@emory.edu",{"facility":153,"status":132,"city":154,"state":155,"zip":156,"country":93,"countryCode":94,"cosmosGeoPoint":157,"geoPoint":161,"contacts":36},"University of Chicago Comprehensive Cancer Center","Chicago","Illinois","60637",{"type":96,"coordinates":158},[159,160],-87.65005,41.85003,{"lat":160,"lon":159},{"facility":163,"status":89,"city":164,"state":165,"zip":166,"country":93,"countryCode":94,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Mayo Clinic","Rochester","Minnesota","55905",{"type":96,"coordinates":168},[169,170],-92.4699,44.02163,{"lat":170,"lon":169},[173,176],{"name":174,"role":80,"phone":36,"phoneExt":36,"email":175},"Lance Pagliaro","pagliaro.lance@mayo.edu",{"name":177,"role":80,"phone":178,"phoneExt":36,"email":179},"Stephen Boorjian \u002FJeffrey Karnes (karnes.r@mayo.edu)","(507)284-4015 \u002F (507)266-9968","boorjian.stephen@mayo.edu",{"facility":181,"status":132,"city":182,"state":183,"zip":184,"country":93,"countryCode":94,"cosmosGeoPoint":185,"geoPoint":189,"contacts":36},"Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":96,"coordinates":186},[187,188],-82.99879,39.96118,{"lat":188,"lon":187},{"facility":191,"status":132,"city":192,"state":193,"zip":194,"country":93,"countryCode":94,"cosmosGeoPoint":195,"geoPoint":199,"contacts":36},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":96,"coordinates":196},[197,198],-97.51643,35.46756,{"lat":198,"lon":197},{"facility":201,"status":132,"city":202,"state":203,"zip":204,"country":93,"countryCode":94,"cosmosGeoPoint":205,"geoPoint":209,"contacts":36},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",{"type":96,"coordinates":206},[207,208],-75.16362,39.95238,{"lat":208,"lon":207},{"facility":211,"status":89,"city":212,"state":213,"zip":214,"country":93,"countryCode":94,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":96,"coordinates":216},[217,218],-95.36327,29.76328,{"lat":218,"lon":217},[221],{"name":75,"role":80,"phone":222,"phoneExt":36,"email":223},"(713)792-3250","cpettawa@mdanderson.org",{"facility":225,"status":89,"city":226,"state":36,"zip":227,"country":228,"countryCode":229,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Velindre NHS Trust","Cardiff","CF14 2TL","United Kingdom","UK",{"type":96,"coordinates":231},[232,233],-3.18,51.48,{"lat":233,"lon":232},[236],{"name":237,"role":80,"phone":36,"phoneExt":36,"email":36},"Dr James Barber",{"facility":239,"status":89,"city":240,"state":36,"zip":241,"country":228,"countryCode":229,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"University Hospitals of Leicester NHS Trust","Leicester","LE1 5WW",{"type":96,"coordinates":243},[244,245],-1.13169,52.6386,{"lat":245,"lon":244},[248],{"name":249,"role":80,"phone":36,"phoneExt":36,"email":36},"Dr Christopher Kent",{"facility":251,"status":132,"city":252,"state":36,"zip":253,"country":228,"countryCode":229,"cosmosGeoPoint":254,"geoPoint":258,"contacts":36},"The Royal Marsden NHS Foundation Trust","London","SM2 5PT",{"type":96,"coordinates":255},[256,257],-0.12574,51.50853,{"lat":257,"lon":256},{"facility":260,"status":89,"city":252,"state":36,"zip":261,"country":228,"countryCode":229,"cosmosGeoPoint":262,"geoPoint":264,"contacts":265},"St George's Hospital NHS Foundation Trust","SW17 0QT",{"type":96,"coordinates":263},[256,257],{"lat":257,"lon":256},[266],{"name":267,"role":80,"phone":36,"phoneExt":36,"email":36},"Mr Nick Watkin",{"facility":269,"status":89,"city":270,"state":36,"zip":271,"country":228,"countryCode":229,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Norfolk and Norwich University Hospitals NHS Foundation Trust","Norwich","NR4 7UY",{"type":96,"coordinates":273},[274,275],1.29834,52.62783,{"lat":275,"lon":274},[278],{"name":279,"role":80,"phone":36,"phoneExt":36,"email":36},"Mr Vivekanandan Kumar",{"facility":281,"status":132,"city":282,"state":36,"zip":283,"country":228,"countryCode":229,"cosmosGeoPoint":284,"geoPoint":288,"contacts":36},"Swansea Bay University Health Board","Swansea","SA6 6NL",{"type":96,"coordinates":285},[286,287],-3.94323,51.62079,{"lat":287,"lon":286},{"type":290,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[292,295],{"name":293,"class":294},"National Cancer Institute (NCI)","NIH",{"name":296,"class":297},"ECOG-ACRIN Cancer Research Group","NETWORK","100232591","phase-3-international-penile-advanced-cancer-trial-international-rare-cancers-initiative-study-100232591",false,"NCT02305654","International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)","InPACT","Inclusion Criteria:\n\n1. Written informed consent\n2. Measurable disease as determined by RECIST (version 1.1) criteria;\n3. Histologically-proven squamous cell carcinoma of the penis,\n4. Stage:\n\n   * any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;\n   * any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;\n   * any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0\n5. Performance Status ECOG 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Pure verrucous carcinoma of the penis,\n2. Nonsquamous malignancy of the penis,\n3. Squamous carcinoma of the urethra,\n4. Stage M1,\n5. Previous chemotherapy or chemoradiotherapy,\n6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.","MALE","18 Years",{"count":308,"type":309},200,"ESTIMATED","INTERVENTIONAL",[312],"PHASE3","This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.\n\nInPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:\n\nA. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).\n\nAfter ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:\n\nP. prophylactic PLND Q. no prophylactic PLND",[315],"Squamous Cell Carcinoma of the Penis, Usual Type",[317,318,319,320,321],"Penis cancer","Chemotherapy","Chemoradiotherapy","Surgery","Phase III","2025-03-27",{"date":324,"type":325},"2025-04-02","ACTUAL",{"date":327,"type":325},"2017-05-12",{"date":329,"type":309},"2027-11-30",{"name":5,"class":6},17]