[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100321524":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":21,"armGroups":29,"interventions":41,"overallOfficials":21,"centralContacts":49,"locations":55,"responsibleParty":243,"collaborators":21,"id":246,"slug":21,"hasResults":247,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":247,"sex":253,"minAge":254,"maxAge":21,"enrollmentInfo":255,"targetDuration":21,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"pathologic complete response (pCR)","Pathologic Complete response on cancer defined as absence of cancer cells on specimen","8-12 weeks",[14,18],{"measure":15,"description":16,"timeFrame":17},"DFS","Disease Free survival","5 years",{"measure":19,"description":20,"timeFrame":17},"OS","Overall Survival",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE","PURPOSE\n\nTo demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the \"minimum\" longer time interval to determine further tumor modifications and the \"a priori\" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy).\n\nPrimary Endpoint\n\n* pCR\n\nSecondary Endpoints\n\n* DFS\n* OS\n* QoL (quality of Life)\n\nSite Eligibility\n\nThe trial is a multicenter collaboration, involving all those centers able to provide the standard of cure for locally advanced rectal cancer. All the involved centers have to respect the following criteria:\n\n* Site able to perform robotic-assisted and standard laparoscopic rectal cancer surgery and TaTME (transanal total mesorectal excision)\n* Site able to provide a preoperative work up according to the work up criteria specified in this trial\n* Site able to provide standard neoadjuvant treatment, both chemo and radiation therapy, according to the criteria specified in this trial\n* Predicted capability to recruit a minimum of 15 patients per year to the trial.\n\nRandomization will take place after consent is obtained and after patients have completed their baseline patient reported questionnaires. Patient consent and randomization will take place as close to the date of start of the neoadjuvant treatment as possible and must be no more than 30 days prior to planned treatment.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Standard Interval Time Arm","ACTIVE_COMPARATOR","Minimally invasive surgery after 8 weeks from chemoradiation treatment",[35],"Procedure: Surgery after 8 weeks from chemoradiation treatment",{"label":37,"type":32,"description":38,"interventionNames":39},"Delayed Interval Time Arm","Minimally invasive surgery after 12 weeks from chemoradiation treatment",[40],"Procedure: Surgery after 12 weeks from chemoradiation treatment",[42,46],{"type":43,"name":44,"description":33,"armGroupLabels":45,"otherNames":21},"PROCEDURE","Surgery after 8 weeks from chemoradiation treatment",[31],{"type":43,"name":47,"description":38,"armGroupLabels":48,"otherNames":21},"Surgery after 12 weeks from chemoradiation treatment",[37],[50],{"name":51,"role":52,"phone":53,"phoneExt":21,"email":54},"Igor Monsellato, MD","CONTACT","+390131206506","igor.monsellato@ospedale.al.it",[56,79,92,108,124,133,147,161,173,189,203,212,226,235],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"SS. Antonio e Biagio e Cesare Arrigo Hospital","RECRUITING","Alessandria","AL","15121","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],8.61007,44.90924,{"lat":68,"lon":67},[71,73,76],{"name":72,"role":52,"phone":21,"phoneExt":21,"email":21},"Igor Monsellato, Md, PhD",{"name":74,"role":75,"phone":21,"phoneExt":21,"email":21},"Igor Monsellato, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":77,"role":78,"phone":21,"phoneExt":21,"email":21},"Fabio Priora, MD","SUB_INVESTIGATOR",{"facility":80,"status":58,"city":81,"state":82,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Ospedale Gian Battista Morgagni - Luigi Pierantoni","Forlì","Forlì-Cesena",{"type":65,"coordinates":84},[85,86],12.04144,44.22177,{"lat":86,"lon":85},[89,91],{"name":90,"role":52,"phone":21,"phoneExt":21,"email":21},"Davide Cavaliere, MD",{"name":90,"role":75,"phone":21,"phoneExt":21,"email":21},{"facility":93,"status":58,"city":94,"state":95,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Ospedale Civile Pietro Cosma","Camposampiero","Padua",{"type":65,"coordinates":97},[98,99],11.93534,45.56368,{"lat":99,"lon":98},[102,104,106],{"name":103,"role":52,"phone":21,"phoneExt":21,"email":21},"Enzo Mammano, MD",{"name":105,"role":75,"phone":21,"phoneExt":21,"email":21},"Emilio Morpurgo, MD",{"name":107,"role":78,"phone":21,"phoneExt":21,"email":21},"Tania Contardo, MD",{"facility":109,"status":58,"city":110,"state":111,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Ospedale Sacro Cuore","Negrar","Verona",{"type":65,"coordinates":113},[114,115],10.93899,45.52918,{"lat":115,"lon":114},[118,120,122],{"name":119,"role":52,"phone":21,"phoneExt":21,"email":21},"Giacomo Ruffo",{"name":121,"role":75,"phone":21,"phoneExt":21,"email":21},"Giacomo Ruffo, MD",{"name":123,"role":78,"phone":21,"phoneExt":21,"email":21},"Filippo Alongi, Prof",{"facility":125,"status":126,"city":127,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":128,"geoPoint":132,"contacts":21},"Ente Ecclesiastico ospedale generale Regionale Miulli","SUSPENDED","Acquaviva delle Fonti",{"type":65,"coordinates":129},[130,131],16.8433,40.89704,{"lat":131,"lon":130},{"facility":134,"status":58,"city":135,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Ospedale degli Infermi","Biella",{"type":65,"coordinates":137},[138,139],8.05796,45.56304,{"lat":139,"lon":138},[142,144,145],{"name":143,"role":52,"phone":21,"phoneExt":21,"email":21},"Roberto Perinotti, MD",{"name":143,"role":75,"phone":21,"phoneExt":21,"email":21},{"name":146,"role":78,"phone":21,"phoneExt":21,"email":21},"Roberto Polastri, MD",{"facility":148,"status":58,"city":149,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Istituto del Radio Olindo Alberti, Spedali Civili di Brescia","Brescia",{"type":65,"coordinates":151},[152,153],10.21472,45.53558,{"lat":153,"lon":152},[156,159],{"name":157,"role":52,"phone":21,"phoneExt":21,"email":158},"Marco LF Bonù, MD","marco.bonu@unibs.it",{"name":160,"role":78,"phone":21,"phoneExt":21,"email":21},"Vittorio Morelli, MD",{"facility":162,"status":58,"city":163,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"ASST Ospedale di Cremona","Cremona",{"type":65,"coordinates":165},[166,167],10.02129,45.13325,{"lat":167,"lon":166},[170],{"name":171,"role":52,"phone":21,"phoneExt":21,"email":172},"Gianluca Baiocchi, Prof","gianluca.baiocchi@unibs.it",{"facility":174,"status":58,"city":175,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Azienda Ospedaliera Universitaria Careggi","Florence",{"type":65,"coordinates":177},[178,179],11.24626,43.77925,{"lat":179,"lon":178},[182,184,185,187],{"name":183,"role":52,"phone":21,"phoneExt":21,"email":21},"Federico Perna, MD",{"name":183,"role":75,"phone":21,"phoneExt":21,"email":21},{"name":186,"role":78,"phone":21,"phoneExt":21,"email":21},"Benedetta Menegatti, MD",{"name":188,"role":78,"phone":21,"phoneExt":21,"email":21},"Andrea Coratti, Prof",{"facility":190,"status":58,"city":191,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Ospedale Maggiore Policlinico Fondazione Ca' Granda","Milan",{"type":65,"coordinates":193},[194,195],12.59836,42.78235,{"lat":195,"lon":194},[198,200,201],{"name":199,"role":52,"phone":21,"phoneExt":21,"email":21},"Luigi Boni, FACS",{"name":199,"role":75,"phone":21,"phoneExt":21,"email":21},{"name":202,"role":78,"phone":21,"phoneExt":21,"email":21},"Elisa Cassinotti, MD",{"facility":204,"status":58,"city":191,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Ospedale San Raffaele IRCCS",{"type":65,"coordinates":206},[194,195],{"lat":195,"lon":194},[209,211],{"name":210,"role":52,"phone":21,"phoneExt":21,"email":21},"Ugo Elmore",{"name":210,"role":75,"phone":21,"phoneExt":21,"email":21},{"facility":213,"status":58,"city":214,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale","Naples",{"type":65,"coordinates":216},[217,218],14.26811,40.85216,{"lat":218,"lon":217},[221,223,224],{"name":222,"role":52,"phone":21,"phoneExt":21,"email":21},"Paolo Delrio, Prof",{"name":222,"role":75,"phone":21,"phoneExt":21,"email":21},{"name":225,"role":78,"phone":21,"phoneExt":21,"email":21},"Daniela Rega, MD",{"facility":227,"status":228,"city":229,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":230,"geoPoint":234,"contacts":21},"Ospedale San Francesco","TERMINATED","Nuoro",{"type":65,"coordinates":231},[232,233],9.32568,40.31991,{"lat":233,"lon":232},{"facility":236,"status":126,"city":237,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":238,"geoPoint":242,"contacts":21},"Azienda Ospedaliera San Giovanni - Addolorata","Roma",{"type":65,"coordinates":239},[240,241],11.10642,44.99364,{"lat":241,"lon":240},{"type":75,"investigatorFullName":244,"investigatorTitle":245,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Igor Monsellato","Principal Investigator","100321524",false,"NCT03465982","Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer","Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial","TiMiSNAR","Inclusion Criteria:\n\n* Age \\>18 years\n* cT3\u002F4N0\u002F+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3\n* Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)\n* Histologically-proven adenocarcinoma of the rectum\n* Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)\n* Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)\n* Eligible for chemoradiation treatment\n* Able to give written informed consent\n* Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)\n\nExclusion Criteria:\n\n* Metastatic disease\n* Squamous carcinoma of the anal canal\n* Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)\n* History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements\n* Pregnancy\n* Unable to complete neoadjuvant treatment\n* Unable to give free informed consent\n* Previous radiation treatment on the pelvis\n* Inflammatory bowel disease\n* Hereditary colorectal disease\n* Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer\n* Participation in another rectal cancer clinical trial relating to the topic of this trial","ALL","18 Years",{"count":256,"type":257},340,"ESTIMATED","INTERVENTIONAL",[260],"NA","The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted\u002Fstandard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted\u002Fstandard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.",[263],"Rectal Cancer",[265,266,267,268,269],"rectal cancer","robotic rectal cancer resection","minimally invasive surgery","Colorectal Cancer","chemoradiation treatment rectal cancer","2024-04-15",{"date":272,"type":273},"2024-04-16","ACTUAL",{"date":275,"type":273},"2018-06-05",{"date":277,"type":257},"2029-06-05",{"name":5,"class":6},14]