[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-stage-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-stage-rectal-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100609027","phase-2-ctdna-informed-management-of-early-stage-rectal-cancer-100609027",false,"NCT07209215","ctDNA-Informed Management of Early-Stage Rectal Cancer","ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","ULTIMATE","Inclusion Criteria:\n\n* Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.\n* Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.\n* Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.\n* Patients ≥18 years of age at time of consent.\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Ability and stated willingness to adhere to the study visit schedule and protocol procedures\u002Frequirements.\n\nExclusion Criteria:\n\n* Prior treatment for rectal cancer, except for cohort B.\n* Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.\n* Patients on hemodialysis.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.",[27,28,29,30],"Rectal Adenocarcinoma","Rectal Cancer","Early-stage Rectal Cancer","Locally Advanced Rectal Adenocarcinoma","NOT_YET_RECRUITING","2026-01-15",{"date":34,"type":35},"2026-01-20","ACTUAL",{"date":37,"type":21},"2026-03",{"date":39,"type":21},"2028-05",{"name":41,"class":42},"University of California, Davis","OTHER"]