[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100232591":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":19,"studyPopulation":19,"armGroups":58,"interventions":87,"overallOfficials":119,"centralContacts":127,"locations":136,"responsibleParty":339,"collaborators":341,"id":348,"slug":19,"hasResults":349,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":349,"sex":354,"minAge":355,"maxAge":19,"enrollmentInfo":356,"targetDuration":19,"studyType":359,"phases":360,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":139,"whyStopped":19,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival","The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.","up to 5 years",[14,17,20,23,25,29,33,37,41,44],{"measure":15,"description":16,"timeFrame":12},"Disease specific survival time","Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death.",{"measure":18,"description":19,"timeFrame":12},"Number of patients experience a grade 3 or 4 toxicity",null,{"measure":21,"description":22,"timeFrame":12},"Disease-free survival time","Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation.\n\nSubsidiary outcome measures will be\n\n* locoregional recurrence free survival time (LRFST).\n* distant metastases free survival time (DMFST).\n* A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation.",{"measure":24,"description":19,"timeFrame":12},"Occurrence of surgical complication",{"measure":26,"description":27,"timeFrame":28},"Is it possible to achieve pathological nodal assessment after chemotherapy","Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy.","12 weeks",{"measure":30,"description":31,"timeFrame":32},"Quality of life","Measured using the EORTC-QLQC30 and Lymphodema-QL","Baseline, 3, 6, 9, 12, 18, 24 and 36 months",{"measure":34,"description":35,"timeFrame":36},"Occurrence of Pathological complete remission","Measured for all patients in InPACT-neoadjuvant:\n\nAbsolute absence of disease on histological examination","Time to complete remission after randomisation",{"measure":38,"description":39,"timeFrame":40},"Operability","Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur.","2-6 weeks",{"measure":42,"description":43,"timeFrame":12},"Occurrence of Lower limb\u002Fscrotal oedema","Occurrence of Lower limb\u002Fscrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema",{"measure":45,"description":46,"timeFrame":47},"On-schedule delivery of neoadjuvant therapy","Feasibility of on-schedule delivery of neoadjuvant therapy","After randomisation up to 12 weeks",[49],{"measure":50,"description":51,"timeFrame":12},"Acceptability of randomisation","In addition to the outcome measures, the acceptability of both randomisations will be monitored based on the proportion of eligible patients approached for randomisation, the proportion of approached patients consenting to randomisation and the proportion of randomised patients receiving their allocated treatment. This will provide ongoing information regarding the feasibility of the trial successfully completing to target.",{"allocation":53,"interventionModel":54,"interventionModelDescription":19,"primaryPurpose":55,"observationalModel":19,"timePerspective":19,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":19,"whoMasked":19},"NONE",[59,65,73,78,83],{"label":60,"type":61,"description":62,"interventionNames":63},"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.",[64],"Procedure: ILND - Inguinal Lymph Node Dissection",{"label":66,"type":67,"description":68,"interventionNames":69},"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",[70,71,72],"Drug: Paclitaxel","Drug: Ifosfamide","Drug: Cisplatin",{"label":74,"type":67,"description":75,"interventionNames":76},"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.",[72,77],"Radiation: Intensity modulated radiation treatment (IMRT)",{"label":79,"type":67,"description":80,"interventionNames":81},"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.",[82],"Procedure: Prophylactic PLND - pelvic lymph node dissection",{"label":84,"type":85,"description":86,"interventionNames":19},"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",[88,93,100,106,110,115],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":19},"PROCEDURE","ILND - Inguinal Lymph Node Dissection","Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.",[60],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"DRUG","Paclitaxel","Dose 175mg\u002Fm2 as part of TIP regimen.",[66],[99],"Taxol",{"type":94,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Ifosfamide","Dose 900mg\u002Fm2 as part of TIP regimen.",[66],[105],"Mitoxana",{"type":94,"name":107,"description":108,"armGroupLabels":109,"otherNames":19},"Cisplatin","Dose 15mg\u002Fm2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg\u002Fm2 for use concurrently with raditotherapy (chemoradiotherapy arm)",[66,74],{"type":111,"name":112,"description":113,"armGroupLabels":114,"otherNames":19},"RADIATION","Intensity modulated radiation treatment (IMRT)","Treatment with very high energy X-rays (radiotherapy).",[74],{"type":89,"name":116,"description":117,"armGroupLabels":118,"otherNames":19},"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.",[79],[120,124],{"name":121,"affiliation":122,"role":123},"Steve Nicholson","Mid and South Essex NHS Foundation Trust","STUDY_CHAIR",{"name":125,"affiliation":126,"role":123},"Curtis Pettaway","University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org",[128,133],{"name":129,"role":130,"phone":131,"phoneExt":19,"email":132},"UK - InPACT Senior Trial Manager","CONTACT","02087224261","InPACT-icrctsu@icr.ac.uk",{"name":134,"role":130,"phone":135,"phoneExt":19,"email":19},"US\u002FCanada - InPACT DA for EA8134","(857)504-2900",[137,156,165,180,191,202,212,230,240,250,260,274,288,300,309,318,330],{"facility":138,"status":139,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"Los Angeles County-USC Medical Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":146,"coordinates":147},"Point",[148,149],-118.24368,34.05223,{"lat":149,"lon":148},[152],{"name":153,"role":130,"phone":154,"phoneExt":19,"email":155},"Anne Schuckman","(323)865-3700","anne.schuckman@med.usc.edu",{"facility":157,"status":139,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"USC \u002F Norris Comprehensive Cancer Center",{"type":146,"coordinates":159},[148,149],{"lat":149,"lon":148},[162],{"name":163,"role":130,"phone":154,"phoneExt":19,"email":164},"Sia Daneshmand","daneshma@usc.edu",{"facility":166,"status":139,"city":167,"state":168,"zip":169,"country":143,"countryCode":144,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":146,"coordinates":171},[172,173],-82.45843,27.94752,{"lat":173,"lon":172},[176],{"name":177,"role":130,"phone":178,"phoneExt":19,"email":179},"Phil Spiess","(813)745-8343","Philippe.spiess@moffitt.org",{"facility":181,"status":182,"city":183,"state":184,"zip":185,"country":143,"countryCode":144,"cosmosGeoPoint":186,"geoPoint":190,"contacts":19},"Grady Health System","ACTIVE_NOT_RECRUITING","Atlanta","Georgia","30303",{"type":146,"coordinates":187},[188,189],-84.38798,33.749,{"lat":189,"lon":188},{"facility":192,"status":139,"city":183,"state":184,"zip":193,"country":143,"countryCode":144,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Emory University Hospital\u002FWinship Cancer Institute","30322",{"type":146,"coordinates":195},[188,189],{"lat":189,"lon":188},[198],{"name":199,"role":130,"phone":200,"phoneExt":19,"email":201},"Viraj Master","(404)778-4898","vmaster@emory.edu",{"facility":203,"status":182,"city":204,"state":205,"zip":206,"country":143,"countryCode":144,"cosmosGeoPoint":207,"geoPoint":211,"contacts":19},"University of Chicago Comprehensive Cancer Center","Chicago","Illinois","60637",{"type":146,"coordinates":208},[209,210],-87.65005,41.85003,{"lat":210,"lon":209},{"facility":213,"status":139,"city":214,"state":215,"zip":216,"country":143,"countryCode":144,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Mayo Clinic","Rochester","Minnesota","55905",{"type":146,"coordinates":218},[219,220],-92.4699,44.02163,{"lat":220,"lon":219},[223,226],{"name":224,"role":130,"phone":19,"phoneExt":19,"email":225},"Lance Pagliaro","pagliaro.lance@mayo.edu",{"name":227,"role":130,"phone":228,"phoneExt":19,"email":229},"Stephen Boorjian \u002FJeffrey Karnes (karnes.r@mayo.edu)","(507)284-4015 \u002F (507)266-9968","boorjian.stephen@mayo.edu",{"facility":231,"status":182,"city":232,"state":233,"zip":234,"country":143,"countryCode":144,"cosmosGeoPoint":235,"geoPoint":239,"contacts":19},"Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":146,"coordinates":236},[237,238],-82.99879,39.96118,{"lat":238,"lon":237},{"facility":241,"status":182,"city":242,"state":243,"zip":244,"country":143,"countryCode":144,"cosmosGeoPoint":245,"geoPoint":249,"contacts":19},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":146,"coordinates":246},[247,248],-97.51643,35.46756,{"lat":248,"lon":247},{"facility":251,"status":182,"city":252,"state":253,"zip":254,"country":143,"countryCode":144,"cosmosGeoPoint":255,"geoPoint":259,"contacts":19},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",{"type":146,"coordinates":256},[257,258],-75.16362,39.95238,{"lat":258,"lon":257},{"facility":261,"status":139,"city":262,"state":263,"zip":264,"country":143,"countryCode":144,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"University of Texas M.D. Anderson Cancer Center","Houston","Texas","77030",{"type":146,"coordinates":266},[267,268],-95.36327,29.76328,{"lat":268,"lon":267},[271],{"name":125,"role":130,"phone":272,"phoneExt":19,"email":273},"(713)792-3250","cpettawa@mdanderson.org",{"facility":275,"status":139,"city":276,"state":19,"zip":277,"country":278,"countryCode":279,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Velindre NHS Trust","Cardiff","CF14 2TL","United Kingdom","UK",{"type":146,"coordinates":281},[282,283],-3.18,51.48,{"lat":283,"lon":282},[286],{"name":287,"role":130,"phone":19,"phoneExt":19,"email":19},"Dr James Barber",{"facility":289,"status":139,"city":290,"state":19,"zip":291,"country":278,"countryCode":279,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"University Hospitals of Leicester NHS Trust","Leicester","LE1 5WW",{"type":146,"coordinates":293},[294,295],-1.13169,52.6386,{"lat":295,"lon":294},[298],{"name":299,"role":130,"phone":19,"phoneExt":19,"email":19},"Dr Christopher Kent",{"facility":301,"status":182,"city":302,"state":19,"zip":303,"country":278,"countryCode":279,"cosmosGeoPoint":304,"geoPoint":308,"contacts":19},"The Royal Marsden NHS Foundation Trust","London","SM2 5PT",{"type":146,"coordinates":305},[306,307],-0.12574,51.50853,{"lat":307,"lon":306},{"facility":310,"status":139,"city":302,"state":19,"zip":311,"country":278,"countryCode":279,"cosmosGeoPoint":312,"geoPoint":314,"contacts":315},"St George's Hospital NHS Foundation Trust","SW17 0QT",{"type":146,"coordinates":313},[306,307],{"lat":307,"lon":306},[316],{"name":317,"role":130,"phone":19,"phoneExt":19,"email":19},"Mr Nick Watkin",{"facility":319,"status":139,"city":320,"state":19,"zip":321,"country":278,"countryCode":279,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Norfolk and Norwich University Hospitals NHS Foundation Trust","Norwich","NR4 7UY",{"type":146,"coordinates":323},[324,325],1.29834,52.62783,{"lat":325,"lon":324},[328],{"name":329,"role":130,"phone":19,"phoneExt":19,"email":19},"Mr Vivekanandan Kumar",{"facility":331,"status":182,"city":332,"state":19,"zip":333,"country":278,"countryCode":279,"cosmosGeoPoint":334,"geoPoint":338,"contacts":19},"Swansea Bay University Health Board","Swansea","SA6 6NL",{"type":146,"coordinates":335},[336,337],-3.94323,51.62079,{"lat":337,"lon":336},{"type":340,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[342,345],{"name":343,"class":344},"National Cancer Institute (NCI)","NIH",{"name":346,"class":347},"ECOG-ACRIN Cancer Research Group","NETWORK","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":357,"type":358},200,"ESTIMATED","INTERVENTIONAL",[361],"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",[364],"Squamous Cell Carcinoma of the Penis, Usual Type",[366,367,368,369,370],"Penis cancer","Chemotherapy","Chemoradiotherapy","Surgery","Phase III","2025-03-27",{"date":373,"type":374},"2025-04-02","ACTUAL",{"date":376,"type":374},"2017-05-12",{"date":378,"type":358},"2027-11-30",{"name":5,"class":6},17]