[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498643":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":38,"locations":47,"responsibleParty":155,"collaborators":157,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":163,"sex":169,"minAge":170,"maxAge":24,"enrollmentInfo":171,"targetDuration":24,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":183,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Contact x-ray brachytherapy","EXPERIMENTAL","Contact x-ray brachytherapy will be given applied after randomisation with a maximum interval of 14 weeks after finishing the neoadjuvant (chemo)radiation. Contact x-ray brachytherapy consists of three fractions of 30Gy per fraction applied to the tumour, with a 2 week interval between each boost. Response evaluation takes place every 3 months thereafter. Patients in whom a clinical complete response is detected during follow-up are offered a watch-and-wait approach; patients in whom an incomplete response or disease progression is noted, completion or salvage TME-surgery is advised.",[13],"Radiation: Contact x-ray brachytherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Extending the waiting interval, with or without local excision","The waiting interval will be extended with 6-8 more weeks after the first response evaluation, followed by a second (or third in case of ongoing response) re-assessment. Patients with a clinical complete response at the time of the second (or third) response evaluation will be offered a watch-and-wait approach without any surgical treatment. Patients with a remaining small lesion will be offered transanal local excision. Depending on the final pathological staging after local excision, patients are categorized as low-risk or high-risk, and will be offered a watch-and-wait strategy or completion TME-surgery, respectively.",[18],"Procedure: Local excision",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"RADIATION","With contact x-ray brachytherapy an intraluminal radiation boost up to 90 Gy is applied to the primary rectal tumour, with minimal collateral damage to the surrounding normal tissues due to minimal penetration of the 50 kVolt therapy.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"PROCEDURE","Local excision","Local excision will basically be performed by the TAMIS-procedure (transanal minimally invasive surgery).",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Brechtje A Grotenhuis, MD, PhD","Antoni van Leeuwenhoek Hospital","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Pim Burger, MD, PhD","Catharina Ziekenhuis Eindhoven",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Barbara M Geubels, MD","CONTACT","0205129001","b.geubels@nki.nl",{"name":32,"role":41,"phone":45,"phoneExt":24,"email":46},"020 239 9111","b.grotenhuis@nki.nl",[48,67,82,96,111,125,140],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Radbouw University Medical Centre","RECRUITING","Nijmegen","Gelderland","6500 HB","Netherlands","NL",{"type":57,"coordinates":58},"Point",[59,60],5.85278,51.8425,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":24,"email":66},"de Wilt, MD, PhD","024 361 1111","hans.dewilt@radboudumc.nl",{"facility":68,"status":50,"city":69,"state":70,"zip":71,"country":54,"countryCode":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Catharina Hospital","Eindhoven","North Brabant","5623EJ",{"type":57,"coordinates":73},[74,75],5.47778,51.44083,{"lat":75,"lon":74},[78],{"name":79,"role":41,"phone":80,"phoneExt":24,"email":81},"Burger, MD, PhD","040 239 9111","pim.burger@catharinaziekenhuis.nl",{"facility":83,"status":50,"city":84,"state":85,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Antoni van Leeuwenhoek","Amsterdam","North Holland","1066CX",{"type":57,"coordinates":88},[89,90],4.88969,52.37403,{"lat":90,"lon":89},[93],{"name":94,"role":41,"phone":95,"phoneExt":24,"email":46},"Grotenhuis, MD, PhD","020-5129111",{"facility":97,"status":50,"city":98,"state":99,"zip":100,"country":54,"countryCode":55,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Deventer Hospital","Deventer","Overijssel","7416 SE",{"type":57,"coordinates":102},[103,104],6.16389,52.255,{"lat":104,"lon":103},[107],{"name":108,"role":41,"phone":109,"phoneExt":24,"email":110},"Talsma, MD, PhD","0570 535 353","k.talsma@dz.nl",{"facility":112,"status":50,"city":113,"state":99,"zip":114,"country":54,"countryCode":55,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Isala","Zwolle","8025 AB",{"type":57,"coordinates":116},[117,118],6.09444,52.5125,{"lat":118,"lon":117},[121],{"name":122,"role":41,"phone":123,"phoneExt":24,"email":124},"van Westreenen, MD, PhD","088 624 5000","h.l.van.westreenen@isala.nl",{"facility":126,"status":50,"city":127,"state":128,"zip":129,"country":54,"countryCode":55,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Medical Center Leeuwarden","Leeuwarden","Provincie Friesland","8934 AD",{"type":57,"coordinates":131},[132,133],5.80973,53.20271,{"lat":133,"lon":132},[136],{"name":137,"role":41,"phone":138,"phoneExt":24,"email":139},"Hoff, MD","058 286 6666","c.hoff@mcl.nl",{"facility":141,"status":50,"city":142,"state":143,"zip":144,"country":54,"countryCode":55,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Ijsselland Hospital","Capelle aan den IJssel","South Holland","2906 ZC",{"type":57,"coordinates":146},[147,148],4.57778,51.92917,{"lat":148,"lon":147},[151],{"name":152,"role":41,"phone":153,"phoneExt":24,"email":154},"Vermaas, MD, PhD","010 258 5000","mvermaas@ysl.nl",{"type":156,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[158,159],{"name":37,"class":6},{"name":160,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100498643","organ-preservation-in-rectal-cancer-contact-x-ray-brachytherapy-vs-extending-the-waiting-interval-and-local-excision-100498643",false,"NCT05772923","Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision","Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision","OPAXX","Inclusion Criteria:\n\n* histologically verified adenocarcinoma above the dentate line and within 10cm of the anal verge;\n* neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed response evaluation according to the Dutch national guidelines (cT1-3, cN1-2 lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without pres-ence of significant distant metastases) without full dose chemotherapy in the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR\n* neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1) LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal status, lateral lymph node involvement, and\u002For involved MRF, without the presence of significant distant metastases) or 2) early rectal cancer or IRC and a strong wish for organ preservation;\n* clinically near-complete response or a small residual tumour mass \\\u003C3 cm;\n* technically feasible to perform both treatment options (contact x-ray brachytherapy or local excision);\n* age \\>18 years;\n* written informed consent.\n\nExclusion Criteria:\n\n* neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation, e.g. patients with a Rapido or M1-scheme are not eligible;\n* radiation dose \\>50.4 Gy or boost dose on the primary tumour;\n* presence of suspicious lymph nodes (yN1\u002FN2) at first response evaluation;\n* residual tumour ≥ 3cm or over half of the circumference of the rectal lumen;\n* patients who are unable to undergo contact x-ray brachytherapy or local excision;\n* patients who cannot tolerate a completion- or salvage-TME because of comorbidity or frailty;","ALL","18 Years",{"count":172,"type":173},168,"ESTIMATED","INTERVENTIONAL",[176],"NA","The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.",[179,180,181,182],"Organ Preservation","Rectal Cancer","Quality of Life","Locally Advanced Rectal Carcinoma",[184,185,186,27,9,187],"Organ preservation","Rectal cancer","(Chemo)radiation","TAMIS","2023-03-14",{"date":190,"type":191},"2023-03-17","ACTUAL",{"date":193,"type":191},"2021-04-16",{"date":195,"type":173},"2029-03",{"name":5,"class":6},7]