[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617123":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":26,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":26},{"fullName":5,"class":6},"St. James's Hospital, Ireland","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Total Neoadjuvant Therapy and GLP-1 Receptor Agonist","EXPERIMENTAL","This arm will have patients with increased BMI and locally advanced rectal cancer having total neoadjuvant chemoradiotherapy. This arm will be given a GLP-1 receptor agonist",[13,14],"Drug: GLP-1 receptor agonist","Drug: Total neoadjuvant therapy (TNT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Locally advanced rectal cancer and total neoadjuvant therapy alone","ACTIVE_COMPARATOR","Patients with a high BMI and locally advanced rectal cancer undergoing total neoadjuvant therapy with not receiving a GLP-1 receptor agonist",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","GLP-1 receptor agonist","All patients will receive standard total neoadjuvant therapy for rectal cancer as per local standards. One group will receive a GLP-1 rector agonist in addition to the standard treatment for rectal cancer",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Total neoadjuvant therapy (TNT)","Total ne-adjuvant therapy is standard treatment for locally advanced rectal cancer",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Michael Kelly, MB BAO BCH PHD FRCSI","St. James Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Michael Eamon Kelly, MB BAO BCH PhD FRCSI","CONTACT","00353876638956","kellym11@tcd.ie",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Ben Creavin, MB BAO BCH MD FRCSI","00353877830130","bencreavin@rcsi.com",{"type":35,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ben Creavin","Colorectal Surgeon","100617123","phase-2-evaluating-the-impact-of-glp-1-receptor-agonists-with-total-neoadjuvant-therapy-in-rectal-cancer-100617123",false,"NCT07314528","Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer","A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Written informed consent according to local guidelines obtained prior to any study-related activities.\n* Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum.\n* BMI ≥25 kg\u002Fm²\n* Radiological confirmed \\>T2, Node positive, Threatened Surgical Margin and\u002For EMVI+ by MRI\n* Imaging available for radiomics analysis\n* Absence of metastatic disease at registration.\n* Adequate renal function is defined as calculated creatinine clearance (CrCl) \\>50ml\u002Fmin.\n* ANC \\> 1.5 cells\u002Fmm3, HGB \\> 8.0 gm\u002Fdl, PLT \\> 150,000\u002Fmm3, total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN\n* Able to tolerate medication.\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Received prior chemotherapy or radiotherapy\n* Previous or concurrent active malignancy ≤ 5 years prior to registration, with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating investigator does not feel will impact the study objectives.\n* Locally advanced disease T3N+ or T4 disease.\n* Recurrent rectal cancer\n* Metastatic disease at presentation\n* Patients unable to undergo MRI\n* Patients having already received weight-loss intervention (pharmacological or surgical)","ALL","18 Years",{"count":59,"type":60},42,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is\n\n1. Does the drug increase weight loss in rectal cancer patients with a high BMI\n2. Does the drug improve response rates to chemotherapy and radiotherapy\n3. Does the drug improve survival outcomes and if cancer returns\n\nResearchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug\n\nPatients will be required to\n\n1\\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols\n\nBody weight will be measured at three predefined time points:\n\n1. Baseline: Prior to initiation of semaglutide or TNT\n2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation)\n3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery\n\nPatients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer",[66,67,68,69,70],"Rectal Cancer Patients","Obesity &Amp; Overweight","Locally Advanced Rectal Cancer (LARC)","Total Neoadjuvant Therapy","GLP-1",[72,69,73],"Locally Advanced Rectal Cancer","GLP-1 Receptor Agonist","NOT_YET_RECRUITING","2025-12-17",{"date":77,"type":78},"2026-01-02","ACTUAL",{"date":80,"type":60},"2026-04",{"date":82,"type":60},"2028-09",{"name":5,"class":6}]