[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369819":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":47,"responsibleParty":94,"collaborators":27,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":27,"enrollmentInfo":106,"targetDuration":27,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":27,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Vejle Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"A: Standard chemoradiotherapy","ACTIVE_COMPARATOR","50.4 Gy to the tumor and elective volume. The dose is given in 28 fractions on weekdays concomitantly with capecitabine 825 mg\u002Fm2 twice daily on weekdays.",[13,14],"Radiation: 50.4 Gy to the tumor and elective volume","Drug: Capecitabine 825 mg\u002Fm2 twice daily on weekdays",{"label":16,"type":17,"description":18,"interventionNames":19},"B: High-dose radiotherapy","EXPERIMENTAL","62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume. The dose is given in 28 fractions on weekdays concomitantly with capecitabine 825 mg\u002Fm2 twice daily on weekdays",[20,14],"Radiation: 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","50.4 Gy to the tumor and elective volume","Standard radiotherapy",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume","Experimental radiotherapy",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DRUG","Capecitabine 825 mg\u002Fm2 twice daily on weekdays","Standard chemotherapy",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Lars H Jensen, MD, PhD","Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":27,"email":46},"CONTACT","+45 7940 6802","lars.henrik.jensen@rsyd.dk",[48,60,68,76,84],{"facility":49,"status":50,"city":51,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":27},"Aalborg University Hospital","RECRUITING","Aalborg","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],9.9187,57.048,{"lat":58,"lon":57},{"facility":61,"status":50,"city":62,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":63,"geoPoint":67,"contacts":27},"Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital","Copenhagen",{"type":55,"coordinates":64},[65,66],12.56553,55.67594,{"lat":66,"lon":65},{"facility":69,"status":50,"city":70,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":27},"Zealand University Hospital, Næstved","Næstved",{"type":55,"coordinates":72},[73,74],11.76092,55.22992,{"lat":74,"lon":73},{"facility":77,"status":50,"city":78,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":79,"geoPoint":83,"contacts":27},"Zealand University Hospital, Roskilde","Roskilde",{"type":55,"coordinates":80},[81,82],12.08035,55.64152,{"lat":82,"lon":81},{"facility":85,"status":50,"city":86,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Department of Oncology, Vejle Hospital","Vejle",{"type":55,"coordinates":88},[89,90],9.5357,55.70927,{"lat":90,"lon":89},[93],{"name":39,"role":44,"phone":27,"phoneExt":27,"email":46},{"type":95,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100369819","phase-3-standard-dose-versus-high-dose-of-radiotherapy-in-rectal-preservation-with-chemo-radiotherapy-in-rectal-cancer-patients-100369819",false,"NCT04095299","Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients","Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)","WW3","Inclusion Criteria:\n\n* Histopathologically verified adenocarcinoma of the rectum\n* MDT conference finds patient a candidate for rectal resection\n* Clinical tumor category cT1-3\n* MRI findings\n\n  * Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum)\n  * Lowest edge of tumor located at or below the peritoneal reflection on MRI\n* Performance status 0-2\n* Age ≥ 18 years\n* Eligible for radiotherapy and capecitabine according to investigator, including\n\n  * Adequate function of bone marrow (neutrophils ≥ 1.5 x 10\\^9\u002Fl and thrombocytes ≥ 100 x 10\\^9\u002Fl)\n  * Adequate function of liver (ALAT \\\u003C 2.5 x upper limit of normal, bilirubin \\\u003C 2.5 x upper limit of normal)\n  * Adequate kidney function (Serum creatinine \\\u003C 1.5 x upper limit of normal or measured GFR \\> 30 ml\u002Fmin)\n* Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment\n* Written and orally informed consent\n\nExclusion Criteria:\n\n* Previous surgical treatment of the present cancer, including transanal excision of tumor\n* Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ\n* Distant metastases verified by imaging or biopsy, i.e. cM1\n* Previous radiation treatment of the pelvis\n* Pregnant or breastfeeding women.\n* Existing colostomy or ileostomy","ALL","18 Years",{"count":107,"type":108},162,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level.\n\nThe aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.",[114],"Cancer of Rectum","2026-01-06",{"date":117,"type":118},"2026-01-08","ACTUAL",{"date":120,"type":118},"2020-01-20",{"date":122,"type":108},"2033-12",{"name":5,"class":6},5]