[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampullary-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampullary-adenocarcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,91,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100614693","phase-2-trial-comparing-standard-of-care-therapy-with-and-without-sequential-cytoreductive-intervention-for-patients-with-metastatic-foregut-adenocarcinoma-and-undetectable-circulating-tumor-deoxyribose-nucleic-acid-ctdna-levels-100614693",false,"NCT07282912","Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","OLIGOMETS","Inclusion Criteria:\n\n* Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.\n\n  a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if necessary.\n* Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo\u002Fradioembolization (cholangiocarcinomas).\n* Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:\n\n  1. Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation\u002Fablative therapy\n  2. Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).\n  3. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).\n  4. Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.\n  5. Distant metastasis must be limited to two of the above-mentioned sites (a-d).\n  6. If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.\n* Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.\n* Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.\n* Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.\n* Patients must have at least 4 months of prior effective systemic therapy.\n* Has hemoglobin ≥ 8 g\u002FdL.\n* Has ANC ≥ 1500\u002FuL.\n* Has platelet count ≥ 75000\u002FuL.\n* Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* Has aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 5 times ULN.\n* Has creatinine clearance ≥ 50 mL\u002Fmin.\n* Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* Has developed progressive disease on current line of systemic therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past three years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known CNS metastasis and\u002For carcinomatous meningitis.\n* Has known osseous metastasis.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.\n* Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).\n* Has a primary tumor that is not amenable to the treatment modalities listed in section 3.\n* Has albumin level less than 3.0 g\u002FdL despite appropriate nutritional support. Diagnostic Assessments\n* Has detectable ctDNA at the time of enrollment.\n* Has an active infection requiring systemic therapy.\n* Has known active TB\u002FCOVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.\n* Inability to receive chemotherapy and\u002For surgery and\u002For radiotherapy and\u002For ablative procedures due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.","ALL","18 Years","80 Years",{"count":21,"type":22},54,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.",[28,29,30,31,32,33,34,35,36],"Foregut Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Adenocarcinoma","Gastric Adenocarcinoma","Pancreas Adenocarcinoma","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma","Gallbladder Adenocarcinoma","Intra - and Extrahepatic Cholangiocarcinoma",[38,39,40,41,42,43,44,45,46],"Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Oligometastasis","Esophageal adenocarcinoma","Gastroesophageal adenocarcinoma,","Gastric adenocarcinoma","Duodenal adenocarcinoma","Pancreatic\u002Fampullary adenocarcinoma","Gallbladder adenocarcinoma","Intra- and extrahepatic cholangiocarcinoma.","RECRUITING","2026-06-17",{"date":50,"type":51},"2026-06-22","ACTUAL",{"date":53,"type":51},"2026-06-02",{"date":55,"type":22},"2028-06",{"name":57,"class":58},"Yale University","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":59},"100448178","phase-1-efficacy-and-safety-of-tpiat-for-resectable-adenocarcinoma-of-the-pancreas-region-at-high-risk-of-postoperative-fistula-100448178","NCT05116072","Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula","Efficacy and Safety of Total Pancreatectomy With Intraportal Islet Autotransplantation for Resectable Adenocarcinoma of the Cephalic Region of the Pancreas at High-risk of Postoperative Fistula and Requiring Systemic Adjuvant Chemotherapy","TPIAT-01","Inclusion criteria\n\nInclusion criteria are composed of preoperative conditions validated by intraoperative confirmation to plan an exit of the protocol if the pancreas does not finally appear with a high-risk of CR-POPF.\n\n* Age ≥ 18 years\n* Locale resectable invasive adenocarcinomas located in the cephalic region of the pancreas documented by endoscopic ultrasonography with fine-needle aspiration biopsy\n* pancreatic adenocarcinoma;\n* duodenal adenocarcinoma;\n* ampullary adenocarcinoma;\n* and IPMNs with adenocarcinoma degeneration;\n* A potentially curative strategy with primary tumor resection approved by a multidisciplinary expert team\n* A high-risk of CR-POPF\n\n  1. Suspected during preoperative evaluation by the presence of 2 or more of the following criteria (screening criteria of inclusion) : sex male;an obesity (BMI ≥ 30 kg\u002Fm2);a main pancreatic duct diameter ≤ 3 mm on preoperative endoscopic ultrasonography a visceral obesity (i.e. a visceral fat area \\> 84 cm2) ; a sarcopenia (i.e. a skeletal muscle index \\\u003C 43 cm2\u002Fm2 in men with a BMI of \\\u003C25 kg\u002Fm2 or \\\u003C53 cm2\u002Fm2 in men with a BMI of ≥25 kg2\u002Fm2, and \\\u003C41 cm2\u002Fm2 in women)\n  2. and validated during intraoperative evaluation (finale inclusion) by a probability score above or equal to 20% on the validated updated alternative Fistula Risk Score ua-FRS for pancreaticoduodenectomy (ua-FRS) based of pancreas texture, duct size, BMI, sex .\n* Women of childbearing potential should only be included after a confirmed menstrual period, and a negative highly sensitive urine or serum pregnancy test and must agree to be subjected to a monthly pregnancy test (urine or blood) until the end of the relevant systemic exposure to chemotherapy agents, in accordance with current CTFG recommendations (Recommendations related to contraception and pregnancy testing in clinical trials);\n* Women of child-bearing potential and male subjects must agree to use a birth control methods which may be considered as highly effective (failure rate of less than 1% per year ) as recommended by the CTFG (Cinical Trials Facilitation and Coordination Group, version 1.1). These recommandations related to contraception and pregnancy testing in clinical trials suggested such method (see below) that will be use during chemotherapy exposure for included women of child-bearing potential and woman of child-bearing potential when partner of included male : combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal) ; progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable) ; intrauterine device (IUD) ; intrauterine hormone-releasing system ( IUS) ; bilateral tubal occlusion; vasectomised partner ;sexual abstinence For included male partner of a women of child-bearing potential, contraception with condom.\n\nContraception will be perform during the relevant systemic exposure to chemotherapy agents and will be extended by 6 months for women of childbearing potential and by 1 month for men included as recommended by the CTFG\n\n* Patient covered by a health insurance system\n* Patient who provides a written informed consent to participate to the study\n\nExclusion criteria\n\n* Patient will be screened and excluded if they present a preoperative diabetes defined by a stimulated C-peptide \\\u003C 0.5 ng\u002FmL relative to blood glucose \\> 2 g\u002FdL, at 2 hours in post prandial\n* Patients with a known or highly suspected genetic syndrome associated with a risk of pancreatic adenocarcinoma: familial pancreatic cancer, multiple familial melanoma, Peutz-Jeghers syndrome, hereditary chronic pancreatitis, cystic fibrosis, familial breast Ovarian Cancer, Lynch syndrome, adenomatous polyposis family, Li Fraumeni syndrome, Multi-endocrine disorder type I;\n* Multifocal pancreatic adenocarcinomas identified during preoperative evaluation;\n* Performance status and comorbidity profile inappropriate for a major abdominal surgery;\n* Contraindication for autologous islet intraportal transplantation\n* Current or indicated\u002Fscheduled neoadjuvant chemotherapy;\n* Extra pancreatic metastasis identified during preoperative evaluation (high-definition cross-sectional imaging with thorax-abdomen-pelvis multi-detection computed tomography or abdominal MRI with T1, T2 and diffusion weighted sequences) or during intraoperative assessment (clinical examination and ultrasonography);\n* Need for complex vascular reconstructions (endovascular treatment or release of the arcuate ligament will be not considered as complex vascular reconstructions), major vein reconstructions will exclude the patients because of the over-risk of portal thrombosis following islet intraportal infusion.\n* evident macroscopically or biologically proved post biliary drainage pancreatitis that jeopardize islet isolation\n* Known infection or positive serology performed at screening for human immunodeficiency virus (HIV) infection, Hepatitis B or C virus infection, HTLV infection or syphilis infection.\n* Active infection for SARS-CoV-2 virus (positive PCR), which will require rescheduling of the intervention 30 days later.\n* Pregnant or breastfeeding woman\n* Dihydropyrimidine dehydrogenase total deficiency\n* Ethics \u002F regulatory criteria :\n\n  * Person unable to understand purposes, benefits and risks of the study and\u002For unable to provide a written informed consent.\n  * Person unable to comply with the whole study schedule.\n  * Person not covered by a health insurance system.\n  * Person kept in detention and\u002For receiving psychiatric medical care and\u002For patients admitted in a social or medical sanatorium.\n  * Person in an emergency situation.",{"count":69,"type":22},36,[71,25],"PHASE1","Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula.\n\nPostoperative complications following pancreaticoduodenectomy can lead to early discontinuation of the complete oncologic strategy, i.e., chemotherapy for malignancy is performed in only about a third of patients who experienced a grade C fistula.\n\nA total pancreatectomy rather than a pancreaticoduodenectomy is an alternative procedure that involves the complete and definitive resection of all pancreatic tissue, eliminating any risk of postoperative pancreatic fistula but is associated with unavoidable endocrine insufficiency and potentially severe metabolic complications, such as \"brittle diabetes\".\n\nTotal Pancreatectomy following by intraportal Islet AutoTransplantation (TPIAT) can prevent \"brittle diabetes\" and improve the quality of life. The endocrine islets can be isolated from the pancreatic surgical specimen with standardized procedures and transplanted in the liver through intraportal infusion, in absence of immunosuppression and allow adequate control of glucose metabolism with a reduced need for exogenous insulin and an effective graft function in 70% of cases at 3 years Thereby, the investigators hypothesize that total pancreatectomy with intraportal Islet autotransplantation rather than classical pancreaticuduodenectomy, in patients with high-risk of postoperative fistula will increase the rate of complete access to adjuvant chemotherapy, while maintaining an adequate metabolic control.",[74,75,34],"Adenocarcinoma of the Pancreas","Adenocarcinoma of the Duodenum",[77,78,79,80,81],"the cephalic region of the pancreas","total pancreatectomy","postoperative pancreatic fistula","islet transplantation","adenocarcinoma","2025-09-24",{"date":84,"type":51},"2025-09-25",{"date":86,"type":51},"2022-02-20",{"date":88,"type":22},"2030-02-20",{"name":90,"class":58},"University Hospital, Lille",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":59},"100578644","phase-3-prodige-98--randomized-multicenter-phase-3-trial-of-adjuvant-chemotherapy-with-modified-folfirinox-versus-capecitabine-or-gemcitabine-in-patients-with-resected-ampullary-adenocarcinoma-100578644","NCT06813976","PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma","AMPIRINOX","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma on surgical specimen\n* Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)\n* Adenocarcinoma removed within 12 weeks prior to enrollment\n* Patients ≥ 18 years of age\n* Patient without metastatic disease on CT scan \\\u003C 4 weeks prior to inclusion\n* WHO performance status 0 or 1 (WHO 0 if age \\>75)\n* Normal values of kalemia, magnesemia and calcemiaPatient able to understand and sign the information and informed consent note\n* Women of childbearing age and men who are sexually active with women of childbearing age must agree to use highly effective contraception during the trial treatment at least until 6 months after the end of experimental treatment. Women of childbearing potential must use highly effective contraception at least 9 months after the end of treatment with oxaliplatin\n* Patient affiliated to a social security scheme for France, or equivalents in European countries\n* CA19.9 level \\\u003C 180 U\u002FL at inclusion (post-operative level)\n\nExclusion Criteria:\n\n* Neoadjuvant systemic chemotherapy\n* pT1N0M0 tumors\n* Active infection by HBV, HCV or HIV\n* Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Pre-existing peripheral neuropathy (grade ≥ 2)\n* Unresolved or uncontrolled concomitant medical conditions\n* Neutrophils \\\u003C 1500\u002Fmm3, platelets \\\u003C 150 000\u002Fmm3, Haemoglobin \\\u003C 9 g\u002FdL\n* Total bilirubin \\> 1.5x normal,\n* Creatinine clearance \\\u003C 50 ml\u002Fmin according to MDRD\n* AST or ALT \\> 2.5 x UNL, alkaline phosphatase \\> 2.5x normal at least 15 days after resection\n* Patients with poor nutritional status represented by albuminemia \\\u003C 30.0g\u002Fdl\n* History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure\n* Active and\u002For potentially severe infection\n* Treatment with a strong cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (Treatment with Hypericum perforatum)\n* Patient under treatment by brivudine, or treated by brivudine within 4 weeks prior to beginning of study treatment\n* Concomitant use with St John's Wort\n* QT\u002FQTc interval longer than 450msec for men and longer than 470msec for women on the ECG\n* Hypersensitivity to any of the study products or their excipients\n* Administration of live vaccines within 28 days prior to randomization\n* Other cancer treated within the last 5 years except adequately treated, in situ cervical carcinoma or basocellular\u002Fspinocellular carcinoma\n* chronic bowel disease requiring specific treatment and\u002For intestinal obstruction\n* Pregnant or breastfeeding woman\n* Person under guardianship\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons",{"count":99,"type":22},294,[101],"PHASE3","Ampullary adenocarcinoma (AMPAC) is a rare cancer (0.2% of digestive cancers) affecting the ampulla of Vater. The only curative treatment is surgery, but around 4% of patients recur within 2 years of surgical resection.\n\nThe aim of adjuvant chemotherapy is to reduce the risk of disease recurrence, and the only chemotherapies that can be considered standard to date are capecitabine and gemcitabine.\n\nIn this trial, an alternative experimental treatment strategy using modified FOLFORINOX (mFOLFORINOX) is proposed. It consists of 3 chemotherapies with complementary actions: 5-fluorouracil, irinotecan and oxaliplatin, combined with folic acid a vitamin that enhances the efficacy of 5-fluorouracil.\n\nThis study proposes 2 treatment schemes:\n\n* Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid,\n* group B: mono-chemotherapy with capecitabine or gemcitabine.",[34],"2025-07-10",{"date":106,"type":51},"2025-07-11",{"date":108,"type":51},"2025-07-02",{"date":110,"type":22},"2033-07",{"name":112,"class":58},"Centre Hospitalier Universitaire Dijon",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":59},"100521317","the-adapta-study-adjuvant-chemotherapy-after-curative-intent-resection-of-ampullary-cancer-100521317","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,"100 Years",{"count":124,"type":22},400,"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.",[34],[129,130,131,132,133,134],"pancreatobiliary-type","intestinal-type","mixed\u002Fhybrid-type","adjuvant chemotherapy","CAPOX","FOLFIRINOX","2023-10-03",{"date":137,"type":51},"2023-10-05",{"date":139,"type":51},"2023-07-01",{"date":141,"type":22},"2029-07-01",{"name":143,"class":58},"Fondazione Poliambulanza Istituto Ospedaliero"]