[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568948":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":34,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":32,"enrollmentInfo":76,"targetDuration":32,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","1000 mg (twice a day 500 mg) metformin orally will be administered during a 2-week period. This is followed by the standard of care, which is neoadjuvant chemoradiotherapy, involving paclitaxel (50 mg\u002Fm2), carboplatin (AUC=2), and radiotherapy (23 x 1.8 Gy over five weeks) followed by surgical resection.",[13],"Drug: Metformin",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Twice a day 500mg of metfomrin orally (1000mg\u002Fday) during a 2-week period.",[9],[20],"Glucient",[22,25],{"name":23,"affiliation":5,"role":24},"Sarah Derks, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":5,"role":24},"Hanneke W.M. van Laarhoven, MD, PhD",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Kayla Brugman, Master of Medicine","CONTACT","+3120 44 45869",null,"c.brugman@amsterdamumc.nl",[35,50],{"facility":36,"status":37,"city":38,"state":32,"zip":32,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Amsterdam UMC","NOT_YET_RECRUITING","Amsterdam","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],4.88969,52.37403,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":31,"phoneExt":32,"email":33},"Kayla Brugman",{"facility":36,"status":51,"city":38,"state":32,"zip":32,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"RECRUITING",{"type":42,"coordinates":53},[44,45],{"lat":45,"lon":44},[56],{"name":57,"role":30,"phone":58,"phoneExt":32,"email":33},"C.P. Brugman, MD","02044445869",{"type":24,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Sarah Derks","MD PhD",[63],{"name":64,"class":65},"Cancer Center Amsterdam Research Foundation","UNKNOWN","100568948","phase-2-metformin-as-a-metabolic-intervention-in-oesophageal-adenocarcinomas-to-improve-response-to-neoadjuvant-chemoradiotherapy-100568948",false,"NCT06687876","Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy","Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy.","MEMENTO","Inclusion Criteria:\n\n* Surgical resectable (\\\u003CT4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to undergo neoadjuvant chemoradiotherapy.\n* Adult patients (age ≥ 18 years).\n* ECOG performance status 0 or 1 (cf. Appendix A).\n* Adequate hematological, renal and hepatic functions defined as:\n\n  * Absolute Neutrophil Count ≥ 1.5 x 10\\^9\u002FL\n  * Platelets ≥ 100 x 10\\^9\u002FL\n  * Hemoglobin ≥ 5.6 mmol\n  * Total bilirubin ≤ 1.5 x upper normal limit\n  * Creatinine clearance (Cockroft) \\> 30 ml\u002Fmin\n* Patients must be willing to undergo two endoscopies for investigational purposes.\n* Written, voluntary informed consent.\n* Patients must be accessible to follow up and management in the treatment center.\n\nExclusion Criteria:\n\n* Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.\n* Patients prescribed metformin or another anti-diabetic drug for any reason.\n* Patients allergic or intolerant to metformin.\n* Excessive alcohol consumption.\n* Use of OCT1\u002FOCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib).\n* Use of OCT1\u002FOCT2 inducers (e.g. rifampicine).\n* Use of immunosuppressive medication (corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, cyclophosphamide).\n* Previous systemic therapy or radiotherapy on the oesophagus.\n* Severe renal impairment (CLcr ≤ 30 ml\u002Fmin).\n* Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of oesophageal cancer.\n* Previous systemic therapy for other forms of cancer within the last six months.\n* Patients with prior allogeneic stem cell or solid organ transplantation\n* Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.\n* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.\n* Pulmonary fibrosis, active, non-infectious pneumonitis and\u002For severely impaired lung function precluding major surgery and\u002For radiation.\n* Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.\n* Dementia or altered mental status that would prohibit the understanding and giving of informed consent.","ALL","18 Years",{"count":77,"type":78},14,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The primary objective of this study is to investigate whether two weeks of metformin treatment can activate the tumour microenvironment in patients with stage II and III oesophageal adenocarcinomas.",[84,85],"Oesophageal Adenocarcinoma","Tumor Microenvironment",[87,88,89,90,91,92],"metabolic intervention","adenocarcinoma","oesophageal cancer","metformin","tumor microenvironment","neoadjuvant chemoradiotherapy","2025-07-09",{"date":95,"type":96},"2025-07-10","ACTUAL",{"date":98,"type":96},"2025-03-09",{"date":100,"type":78},"2030-12",{"name":5,"class":6},2]