[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100392368":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":16,"studyPopulation":16,"armGroups":74,"interventions":88,"overallOfficials":108,"centralContacts":112,"locations":122,"responsibleParty":293,"collaborators":16,"id":296,"slug":16,"hasResults":297,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":297,"sex":303,"minAge":304,"maxAge":16,"enrollmentInfo":305,"targetDuration":16,"studyType":308,"phases":309,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":140,"whyStopped":16,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":328},{"fullName":5,"class":6},"Catharina Ziekenhuis Eindhoven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with a clear resection margin","A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin \\> 0mm)","Scored within 1 one month of surgery",[14,18,20,22,24,26,30,34,37,40,43,46,50,54,58,62,65],{"measure":15,"description":16,"timeFrame":17},"Local recurrence free survival",null,"Assessed up to 5 years",{"measure":19,"description":16,"timeFrame":17},"Progression free survival",{"measure":21,"description":16,"timeFrame":17},"Metastasis free survival",{"measure":23,"description":16,"timeFrame":17},"Disease free survival",{"measure":25,"description":16,"timeFrame":17},"Overall survival",{"measure":27,"description":28,"timeFrame":29},"Pathologic response","Scored according to Mandard","Scored within 1 month of surgery",{"measure":31,"description":32,"timeFrame":33},"Toxicity induction chemotherapy","Adverse events grade 3 or higher according to the NCI-CTCAE v5.0","Scored until one month after the last administration of the chemotherapy",{"measure":35,"description":16,"timeFrame":36},"Compliance induction chemotherapy","Scored within 1 month after start chemoradiotherapy",{"measure":38,"description":32,"timeFrame":39},"Toxicity chemoradiotherapy","Scored until 3 months after the last administration of the radiotherapy",{"measure":41,"description":16,"timeFrame":42},"Compliance chemoradiotherapy","Evaluation at time of surgery",{"measure":44,"description":16,"timeFrame":45},"Number of patients undergoing surgery","Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy",{"measure":47,"description":48,"timeFrame":49},"Surgical characteristics","including data on intra-operative radiotherapy","Evaluation directly postoperative",{"measure":51,"description":52,"timeFrame":53},"Major surgical morbidity","Clavien-Dindo grade 3 or higher","30 and 90-days postoperative",{"measure":55,"description":56,"timeFrame":57},"Radiological response","mrTRG","Restaging is performed after 3 cycles of CAPOX (1 cycle is 3 weeks) or 4 cycles of CAPOX\u002FFOLFOX (1 cycle is 2 weeks). Second restaging is performed 4-6 weeks after finishing chemoradiotherapy",{"measure":59,"description":60,"timeFrame":61},"Cancer specific quality of life","QLQ-C30","at baseline, 3 months and 12 months postoperative",{"measure":63,"description":64,"timeFrame":61},"Cost-effectiveness","EQ-5D-5L",{"measure":66,"description":67,"timeFrame":61},"Colorectal cancer specific quality of life","QLQ-CR29",{"allocation":69,"interventionModel":70,"interventionModelDescription":16,"primaryPurpose":71,"observationalModel":16,"timePerspective":16,"maskingInfo":72},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":73,"maskingDescription":16,"whoMasked":16},"NONE",[75,83],{"label":76,"type":77,"description":78,"interventionNames":79},"Induction chemotherapy + chemoradiotherapy + surgery","EXPERIMENTAL","Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery",[80,81,82],"Drug: Combination drug","Radiation: Chemoradiotherapy","Procedure: Surgery locally recurrent rectal cancer",{"label":84,"type":85,"description":86,"interventionNames":87},"Neoadjuvant chemotherapy + surgery","ACTIVE_COMPARATOR","Neoadjuvant chemoradiotherapy followed by surgery",[81,82],[89,98,103],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"DRUG","Combination drug","Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg\u002Fm2 BSA IV + capecitabine 1000 mg\u002Fm2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg\u002Fm2 BSA of oxaliplatin IV + 400 mg\u002Fm2 BSA of leucovorin IV + 400 mg\u002Fm2 BSA of bolus 5-fluorouracil IV followed by 2400 mg\u002Fm2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg\u002Fm2 BSA of irinotecan IV + 400 mg\u002Fm2 BSA of leucovorin IV + 400 mg\u002Fm2 BSA of bolus 5-fluorouracil IV followed by 2400 mg\u002Fm2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles.\n\nIf a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX\u002FFOLFIRI.",[76],[95,96,97],"CAPOX","FOLFOX","FOLFIRI",{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":16},"RADIATION","Chemoradiotherapy","Concomitant chemotherapy agent: capecitabine\n\nRadiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.",[76,84],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":16},"PROCEDURE","Surgery locally recurrent rectal cancer","Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon.\n\nIntraoperative radiotherapy is optional.",[76,84],[109],{"name":110,"affiliation":5,"role":111},"Pim Burger, MD","PRINCIPAL_INVESTIGATOR",[113,118],{"name":114,"role":115,"phone":116,"phoneExt":16,"email":117},"Stefi Nordkamp, MD","CONTACT","0031 40 2398858","stefi.nordkamp@catharinaziekenhuis.nl",{"name":119,"role":115,"phone":120,"phoneExt":16,"email":121},"Floor Piqeur, MD","0031 40 2397152","floor.piqeur@catharinaziekenhuis.nl",[123,138,152,160,175,186,197,208,219,230,243,256,271,282],{"facility":124,"status":125,"city":126,"state":16,"zip":16,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"UZ Gent","NOT_YET_RECRUITING","Ghent","Belgium","BE",{"type":130,"coordinates":131},"Point",[132,133],3.71667,51.05,{"lat":133,"lon":132},[136],{"name":137,"role":115,"phone":16,"phoneExt":16,"email":16},"Gabrielle van Ramshorst, MD, PhD",{"facility":139,"status":140,"city":141,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Amsterdam UMC","RECRUITING","Amsterdam","Netherlands","NL",{"type":130,"coordinates":145},[146,147],4.88969,52.37403,{"lat":147,"lon":146},[150],{"name":151,"role":115,"phone":16,"phoneExt":16,"email":16},"Miranda Kusters, MD, PhD",{"facility":153,"status":140,"city":141,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"Antoni van Leeuwenhoek",{"type":130,"coordinates":155},[146,147],{"lat":147,"lon":146},[158],{"name":159,"role":115,"phone":16,"phoneExt":16,"email":16},"Arend Aalbers, MD, PhD",{"facility":161,"status":140,"city":162,"state":16,"zip":163,"country":142,"countryCode":143,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Catharina Hospital","Eindhoven","5623EJ",{"type":130,"coordinates":165},[166,167],5.47778,51.44083,{"lat":167,"lon":166},[170,172],{"name":114,"role":115,"phone":116,"phoneExt":16,"email":171},"pelvex2@catharinaziekenhuis.nl",{"name":173,"role":115,"phone":16,"phoneExt":16,"email":174},"Pim Burger, MD, PhD","pim.burger@catharinaziekenhuis.nl",{"facility":176,"status":140,"city":177,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"University Medical Centre Groningen","Groningen",{"type":130,"coordinates":179},[180,181],6.56667,53.21917,{"lat":181,"lon":180},[184],{"name":185,"role":115,"phone":16,"phoneExt":16,"email":16},"Klaas Havenga, MD, PhD",{"facility":187,"status":140,"city":188,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Leids University Medical Centre","Leiden",{"type":130,"coordinates":190},[191,192],4.49306,52.15833,{"lat":192,"lon":191},[195],{"name":196,"role":115,"phone":16,"phoneExt":16,"email":16},"Fabian Holman, Md, PhD",{"facility":198,"status":140,"city":199,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Haaglanden Medical Centre","Leidschendam",{"type":130,"coordinates":201},[202,203],4.39281,52.08167,{"lat":203,"lon":202},[206],{"name":207,"role":115,"phone":16,"phoneExt":16,"email":16},"Andreas Marinelli, MD, PhD",{"facility":209,"status":140,"city":210,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Maastricht University Medical Centre","Maastricht",{"type":130,"coordinates":212},[213,214],5.68889,50.84833,{"lat":214,"lon":213},[217],{"name":218,"role":115,"phone":16,"phoneExt":16,"email":16},"Jarno Melenhorst, MD, PhD",{"facility":220,"status":140,"city":221,"state":16,"zip":16,"country":142,"countryCode":143,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Erasmus Medical Centre","Rotterdam",{"type":130,"coordinates":223},[224,225],4.47917,51.9225,{"lat":225,"lon":224},[228],{"name":229,"role":115,"phone":16,"phoneExt":16,"email":16},"Cornelis Verhoef, MD, PhD",{"facility":231,"status":125,"city":232,"state":16,"zip":16,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Oslo Universitetssykehus","Oslo","Norway","NO",{"type":130,"coordinates":236},[237,238],10.74609,59.91273,{"lat":238,"lon":237},[241],{"name":242,"role":115,"phone":16,"phoneExt":16,"email":16},"Marianne Guren, MD, PhD",{"facility":244,"status":125,"city":245,"state":16,"zip":16,"country":246,"countryCode":247,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.","Lisbon","Portugal","PT",{"type":130,"coordinates":249},[250,251],-9.1498,38.72509,{"lat":251,"lon":250},[254],{"name":255,"role":115,"phone":16,"phoneExt":16,"email":16},"João Maciel, MD, PhD",{"facility":257,"status":125,"city":258,"state":16,"zip":16,"country":259,"countryCode":260,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Sahlgrenska Universitetssjukhuset","Gothenburg","Sweden","SE",{"type":130,"coordinates":262},[263,264],11.96679,57.70716,{"lat":264,"lon":263},[267,269],{"name":268,"role":115,"phone":16,"phoneExt":16,"email":16},"Eva Angenete, MD, PhD",{"name":270,"role":115,"phone":16,"phoneExt":16,"email":16},"Sofia Heyman, MD, PhD",{"facility":272,"status":125,"city":273,"state":16,"zip":16,"country":259,"countryCode":260,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Skåne Universitetssjukhuset","Malmö",{"type":130,"coordinates":275},[276,277],13.00073,55.60587,{"lat":277,"lon":276},[280],{"name":281,"role":115,"phone":16,"phoneExt":16,"email":16},"Pamela Buchwald, MD, PhD",{"facility":283,"status":125,"city":284,"state":16,"zip":16,"country":259,"countryCode":260,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Karolinska Universitetssjukhuset","Stockholm",{"type":130,"coordinates":286},[287,288],18.06871,59.32938,{"lat":288,"lon":287},[291],{"name":292,"role":115,"phone":16,"phoneExt":16,"email":16},"Henrik Iversen, MD, PhD",{"type":111,"investigatorFullName":294,"investigatorTitle":295,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"J. W. A. Burger","MD, PhD","100392368",false,"NCT04389086","Induction Chemotherapy for Locally Recurrent Rectal Cancer","Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II","PelvEx II","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)\n* Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.\n* WHO performance score 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.\n* Known homozygous DPD deficiency\n* Any chemotherapy in the past 6 months.\n* Any contraindication for the planned chemotherapy, as determined by the medical oncologist.\n* Radiotherapy in the past 6 months for primary rectal cancer.\n* Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and\u002For radiation oncologist.\n* Any contraindication for surgery, as determined by the surgeon and\u002For anaesthesiologist.\n* Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.","ALL","18 Years",{"count":306,"type":307},364,"ESTIMATED","INTERVENTIONAL",[310],"PHASE3","This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)",[313],"Recurrent Rectal Cancer",[315,316,317,318],"Locally recurrent rectal cancer","Neoadjuvant therapy","Induction chemotherapy","Resection margin","2022-09-01",{"date":321,"type":322},"2022-09-06","ACTUAL",{"date":324,"type":322},"2020-11-13",{"date":326,"type":307},"2030-03-01",{"name":5,"class":6},14]