[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554589":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":48,"responsibleParty":84,"collaborators":88,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":28,"enrollmentInfo":103,"targetDuration":28,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"CXB + CRT","ACTIVE_COMPARATOR","Contact x-ray brachytherapy (CXB) (90Gy\u002F3 fractions\u002F4 weeks) and chemoradiotherapy (CRT) 45\u002F50 Gy (1.8\u002F2 Gy\u002Ffraction\u002F5 weeks) with concurrent chemotherapy using capecitabine (900 mg\u002Fm2 bid, on radiation days).",[13,14,15],"Radiation: Radiotherapy","Radiation: Contact x-ray brachytherapy","Drug: Chemotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"CXB + SCRT","EXPERIMENTAL","Contact x-ray brachytherapy (CXB) (90Gy\u002F3 fractions\u002F4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).",[21,14],"Radiation: Short-course radiotherapy",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Radiotherapy","45\u002F50 Gy (1.8\u002F2 Gy\u002Ffraction\u002F5 weeks)",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Short-course radiotherapy","25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Contact x-ray brachytherapy","90Gy\u002F3 fractions\u002F4 weeks",[9,17],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"DRUG","Chemotherapy","Capecitabine (900 mg\u002Fm2 bid, on radiation days)",[9],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Alexander Valdman, MD, PhD","CONTACT","+46 70 002 13 17","alexander.valdman@regionstockholm.se",[49,70],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer","RECRUITING","Stockholm","Solna","171 76","Sweden","SE",{"type":58,"coordinates":59},"Point",[60,61],18.06871,59.32938,{"lat":61,"lon":60},[64,68],{"name":65,"role":45,"phone":66,"phoneExt":28,"email":67},"Per J Nilsson, MD, PhD","+46 724 69 48 14","per.j.nilsson@regionstockholm.se",{"name":65,"role":69,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"facility":71,"status":51,"city":72,"state":28,"zip":73,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Uppsala University Hospital, Colorectal Surgery","Uppsala","751 85",{"type":58,"coordinates":75},[76,77],17.63889,59.85882,{"lat":77,"lon":76},[80],{"name":81,"role":45,"phone":82,"phoneExt":28,"email":83},"Joakim Folkesson, MD, PhD","+46 18 611 00 00","joakim.folkesson@akademiska.se",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Alexander Valdman","National Principal Investigator",[89,91],{"name":90,"class":6},"Uppsala University Hospital",{"name":92,"class":6},"Karolinska Institutet","100554589","contact-radiotherapy-for-rectal-cancer-100554589",false,"NCT06501053","Contact Radiotherapy for Rectal Cancer","Contact Radiotherapy for Rectal Cancer (CORRECT): a Multicenter Randomized Phase II Trial","CORRECT","Inclusion Criteria:\n\n* Adenocarcinoma of the rectum classified as:\n* cT1-cT3ab, \\\u003C 5 cm largest diameter and \\\u003C ½ circumference (MRI staging), N0-N1 (\\\u003C= 3 nodes \\\u003C 8mm diameter), M0\n* Performance status (ECOG) 0-1\n* Operable patient\n* Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm\n* 18 years or above\n* No comorbidity preventing treatment\n* Patient having read the information note and having signed the informed consent\n* Follow-up possible\n\nExclusion Criteria:\n\n* Inoperable patient\n* T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference\n* Distance from the lower tumor border to the anal verge \\>10 cm\n* N2-status at diagnosis or N1 with any node\\>= 8 mm diameter\n* Patient presenting with metastasis at diagnosis (M1)\n* Previous pelvic irradiation\n* Tumor with extramural vascular invasion\n* Poorly differentiated tumor\n* Simultaneous progressive cancer\n* Tumor invading external anal sphincter or growth within 1 mm of the levator\n* Tumor within 1 mm from MRF (mesorectal fascia)\n* Patient unable to receive CXB or CRT\n* Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy\n* Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol\n* Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment\n* Total DPD deficiency","ALL","18 Years",{"count":104,"type":105},110,"ESTIMATED","INTERVENTIONAL",[108],"NA","The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).",[111],"Rectal Cancer",[113,114,115,116],"organ sparing","brachytherapy","radiotherapy","nonoperative","2026-08-06",{"date":119,"type":120},"2026-08-10","ACTUAL",{"date":122,"type":120},"2025-03-03",{"date":124,"type":105},"2032-11",{"name":86,"class":6},2]