[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299553":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":51,"collaborators":20,"id":53,"slug":20,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Mount Sinai Hospital, Canada","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"non-operative management","EXPERIMENTAL","Patients with low rectal cancer who have achieved a complete clinical response following chemoradiotherapy will undergo active follow-up with regular clinical visits, physical exam, endoscopy and imaging assessments at regular intervals for 2 years to assess for tumour re-growth or spread to the liver and lungs",[13],"Procedure: Non-operative management",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Non-operative management","Patients who are eligible and provide informed consent to participate in the trial will undergo non-operative management (i.e., active surveillance for 24 months) according to the schedule outlined in the study protocol.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Erin Kennedy","Sinai Health System","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","416-586-4800","6872","erin.kennedy@sinaihealthsystem.ca",{"name":33,"role":28,"phone":29,"phoneExt":34,"email":35},"Selina Schmocker","2159","selina.schmocker@sinaihealthsystem.ca",[37],{"facility":24,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Toronto","Ontario","M5T 3L9","Canada",{"type":44,"coordinates":45},"Point",[46,47],-79.39864,43.70643,{"lat":47,"lon":46},[50],{"name":23,"role":28,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100299553",false,"NCT03179540","Non-operative Management for Locally Advanced Rectal Cancer","Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer","NOM","Inclusion Criteria:\n\n* Completed chemoradiotherapy (CRT) as standard of care \\[Stage II and Stage III (T3-T4N0, AnyTN1-2)\\]; \\[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\\]\n* Planned or probable APR\n* ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT\n* 18 years or older\n* Provides written consent\n\nExclusion Criteria:\n\n* Unable to undergo MRI\n* Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)\n* Pregnancy\n* Inflammatory bowel disease\n* More than one primary colorectal cancer\n* Other malignancy within 5 years of treatment for current rectal cancer\n* Unfit for surgery","ALL","18 Years",{"count":63,"type":64},90,"ESTIMATED","INTERVENTIONAL",[67],"NA","This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.",[70],"Rectal Neoplasms",[72,73,74],"Low Rectal Cancer","Complete Clinical Response","Non-operative Management","2026-06-19",{"date":77,"type":78},"2026-06-23","ACTUAL",{"date":80,"type":78},"2018-03-16",{"date":82,"type":64},"2028-12",{"name":5,"class":6},1]