[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624454":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":53,"locations":59,"responsibleParty":74,"collaborators":78,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":52,"enrollmentInfo":116,"targetDuration":52,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":129,"overallStatus":135,"whyStopped":52,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Low and medium surgical risk participants with stage I-II CRC","EXPERIMENTAL","These participants receive 1 cycle of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response",[13,14],"Drug: 1 Cycle of Pembrolizumab","Drug: Additional Cycle of Pembrolizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Low and medium surgical risk participants with stage III CRC","These participants receive 2 cycles of up-front pembrolizumab before disease re-assessment (no additional cycles are offered if non-complete response)",[19],"Drug: 2 Cycles of Pembrolizumab",{"label":21,"type":22,"description":23,"interventionNames":24},"High surgical risk participants with stage I-II CRC","ACTIVE_COMPARATOR","These participants receive 2 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response",[19,14],{"label":26,"type":22,"description":27,"interventionNames":28},"High surgical risk participants with stage III CRC","These participants receive 3 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response",[29,14],"Drug: 3 Cycles of Pembrolizumab",[31,38,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","1 Cycle of Pembrolizumab","1 cycle of 4mg\u002Fkg (maximum of 400mg) every 6 weeks",[9],[37],"Keytruda",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"2 Cycles of Pembrolizumab","2 Cycles of Pembrolizumab 4mg\u002Fkg (maximum of 400mg) every 6 weeks",[21,16],[37],{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"3 Cycles of Pembrolizumab","3 Cycles of Pembrolizumab 4mg\u002Fkg (maximum of 400mg) every 6 weeks",[26],[37],{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Additional Cycle of Pembrolizumab","An additional 4mg\u002Fkg (maximum of 400mg) cycle of pembrolizumab in the case of non-complete response",[21,26,9],null,[54],{"name":55,"role":56,"phone":57,"phoneExt":52,"email":58},"Ismail Gögenur, Professor","CONTACT","+4526336426","igo@regionsjaelland.dk",[60],{"facility":5,"status":52,"city":61,"state":52,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Køge","4600","Denmark","DK",{"type":66,"coordinates":67},"Point",[68,69],12.18214,55.45802,{"lat":69,"lon":68},[72],{"name":73,"role":56,"phone":57,"phoneExt":52,"email":58},"Ismail Gögenur Professor",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"SPONSOR_INVESTIGATOR","Ismail Gögenur","Professor, MD, DMSc, Consultant",[79,81,83,85,87,89,91,93,95,97,99,101,103,104],{"name":80,"class":6},"Rigshospitalet, Denmark",{"name":82,"class":6},"Bispebjerg Hospital",{"name":84,"class":6},"Herlev and Gentofte Hospital",{"name":86,"class":6},"Gødstrup Hospital",{"name":88,"class":6},"Horsens Hospital",{"name":90,"class":6},"Hvidovre University Hospital",{"name":92,"class":6},"Odense University Hospital",{"name":94,"class":6},"Randers Regional Hospital",{"name":96,"class":6},"Slagelse Hospital",{"name":98,"class":6},"Vejle Hospital",{"name":100,"class":6},"Aalborg University Hospital",{"name":102,"class":6},"Aarhus University Hospital",{"name":5,"class":6},{"name":105,"class":6},"University of Copenhagen","100624454","phase-2-neoadjuvant-immunotherapy-and-organ-sparing-treatment-in-patients-with-stage-i-iii-dmmr-colon-cancer-100624454",false,"NCT07409844","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)","RESET C2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Written informed consent\n3. Clinical UICC stage I-III dMMR colon carcinoma\n4. Indication for elective curative-intent surgery\n5. ECOG status 0-2\n\nExclusion Criteria:\n\n1. Patients deemed to be non-surgical candidates by MDT\n2. Patients with a need for emergent surgery due to tumour obstruction\n3. Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s)\n4. Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration.\n5. Patients with colonic stents\n\nAdditional Circumstances:\n\nIn the following circumstances, eligibility will be individually verified:\n\n* Synchronous colonic tumours (may be included if other lesions are biopsy-verified with dMMR status)\n* Concurrent tumours (e.g., patients with prostate cancer may be included if this does not hinder their other cancer treatment or assessments of efficacy)\n\nIn the following circumstance patients may be excluded from the PROMs outcomes:\n\n* Danish language skills insufficient to answer PROMs\n* Unable to use eBoks","ALL","18 Years",{"count":117,"type":118},152,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and\u002For appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.",[124,125,126,127,128],"DMMR Colorectal Cancer","Colon Cancer Stage I","Colon Cancer Stage II\u002FIII","Pembrolizumab","Immunotherapy",[127,130,131,132,133,134],"dMMR","colon cancer","watch-and-wait","organ sparing","neoadjuvant immunotherapy","NOT_YET_RECRUITING","2026-02-17",{"date":138,"type":139},"2026-02-20","ACTUAL",{"date":141,"type":118},"2026-03-01",{"date":143,"type":118},"2031-01-01",{"name":76,"class":6},1]