[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521317":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fondazione Poliambulanza Istituto Ospedaliero","OTHER",[8,14,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Intestinal-type ampullary adenocarcinoma intervention",null,"This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.",[13],"Drug: Capox",{"label":15,"type":10,"description":16,"interventionNames":10},"Intestinal-type ampullary adenocarcinoma control","This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.",{"label":18,"type":10,"description":19,"interventionNames":20},"Pancreatobiliary\u002Fmixed-type ampullary adenocarcinoma intervention","This cohort consist of patients with Pancreatobiliary\u002Fmixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.",[21],"Drug: Folfirinox",{"label":23,"type":10,"description":24,"interventionNames":10},"Pancreatobiliary\u002Fmixed-type ampullary adenocarcinoma control","This cohort consist of patients with Pancreatobiliary\u002Fmixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.",[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Folfirinox","Patients meeting the criteria of post-operative adenocarcinoma of the ampulla of Vater will be enrolled, with adjuvant chemotherapy commencing within 8 weeks of recovery from surgery. Those undergoing palliative intent surgery or palliative chemotherapy are ineligible for the ADAPTA study.\n\nThe ADAPTA study's adjuvant chemotherapy involves 8-12 FOLFIRINOX cycles (Arm 2) repeated 2 weeks. Given patient outcomes, 8 cycles of FOLFIRINOX are deemed sufficient due to completion challenges in prior research. FOLFIRINOX regimen mirrors the modified version from the ACCORD\u002FPRODIGE trial for metastatic pancreatic cancer. This trial adapts mFOLFIRINOX for standard practice.",[18],[32],"leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin.",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Capox","or 8 CAPOX cycles (Arm 1) every 3 weeks.",[9],[38],"Capecitabine and oxaliplatin",[40],{"name":41,"affiliation":42,"role":43},"Moh'd Abu Hilal, MD, PhD","Fondazione Poliambulanza Instituto Ospedaliero","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","+393756326711","abuhilal9@gmail.com",{"name":50,"role":46,"phone":51,"phoneExt":10,"email":52},"Bas Uijterwijk","0640380827","basuijterwijk@live.nl",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Fondazione Poliambulanza","RECRUITING","Brescia","BS","25124","Italy","IT",{"type":63,"coordinates":64},"Point",[65,66],10.21472,45.53558,{"lat":66,"lon":65},[69,70],{"name":41,"role":46,"phone":47,"phoneExt":10,"email":52},{"name":71,"role":46,"phone":51,"phoneExt":10,"email":52},"Bas Uijterwijk, MD",{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[75],{"name":76,"class":6},"Associazione Italiana per la Ricerca sul Cancro","100521317","the-adapta-study-adjuvant-chemotherapy-after-curative-intent-resection-of-ampullary-cancer-100521317",false,"NCT06068023","The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.","The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.","ADAPTA","Inclusion Criteria:\n\n* Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary\u002Fmixed subtype or intestinal subtype\n* After curative resection for ampullary cancer without metastatic disease.\n* WHO performance status 0 or 1\n* Able and willing to receive adjuvant chemotherapy\n* R0\u002F R1 resection\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy, chemotherapy, or resection for AAC.\n* Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC.\n* Pregnancy.\n* R2 resection.\n* Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks)\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator.\n* Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin\n* Inadequate organ functions, characterized by:\n\n  * Leucocytes (WBC) \\\u003C 3.0 X 109\u002Fl\n  * Neutrophils \\\u003C 1.500 (count per microliter of blood)\n  * Platelets \\\u003C 100 x 109 \u002Fl\n  * Hemoglobin \\\u003C 8 mmol\u002Fl\n  * Renal function: E-GFR \\\u003C 50 ml\u002Fmin (serum creatinine \\\u003C 1.5 x UNL)\n  * cholestasis with elevated levels of bilirubin and\u002For alkaline phosphatase \\> 3x UNL (can be improved by biliary drainage if necessary)\n  * elevated transaminases (ALAT\u002FASAT) ≥ 5 x UNL\n  * hypoalbuminemia \\\u003C 2.5 g\u002Fdl\n  * Inadequate coagulation status INR \\> 2 or Quick \\\u003C 50%, aPTT \\>50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.",true,"ALL","18 Years","100 Years",{"count":90,"type":91},400,"ESTIMATED","OBSERVATIONAL","Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.",[95],"Ampullary Adenocarcinoma",[97,98,99,100,101,102],"pancreatobiliary-type","intestinal-type","mixed\u002Fhybrid-type","adjuvant chemotherapy","CAPOX","FOLFIRINOX","2023-10-03",{"date":105,"type":106},"2023-10-05","ACTUAL",{"date":108,"type":106},"2023-07-01",{"date":110,"type":91},"2029-07-01",{"name":5,"class":6},1]