[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-gastroenteropancreatic-tumour\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-gastroenteropancreatic-tumour":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100607216","phase-3-prrt-versus-prrt-plus-chemotherapy-in-gep-net-precedent-trial-100607216",false,"NCT07185672","PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)","PReCedeNT Trial: Phase III Randomised Controlled Open Label Trial of Lutetium 177 PRRT Plus Chemotherapy Versus PRRT Aalone in FDG Avid Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors","PReCedeNT","Inclusion Criteria:\n\n* Male or female, age greater than 18 years\n* Histopathological diagnosis of GEP-NET, necessarily satisfying all the the criteria below\n* Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR\n* Well-differentiated G1 (\\\u003C3%) with disease progression in last 6 months\n* Positive Ga-68-DOTANOC PET\u002FCT, Krennings score \\>\u002F=3\n* Positive FDG PET imaging, grade 3 or 4 uptake\n* Locally advanced\u002Finoperable disease or metastatic disease\n* Karnofsky performance-status score of at least 60 or ECOG performance status \\\u003C\u002F= 2\n* Life expectancy greater than 6 months\n\nExclusion Criteria:\n\n* Serum creatinine level of more than 1.6 mg\u002Fdl or a creatinine clearance of less than 50 ml\u002Fmin\n* Hemoglobin level of less than 8.0 g per deciliter\n* Red blood cell count noty less than 300,000\u002Fcubic millimeter White cell count of less than 2000 per cubic millimeter\n* Platelet count of less than 75,000 per cubic millimetre\n* Total bilirubin level of more than 3 times the upper limit of the normal range\n* Serum albumin level \\\u003C 3.0 g\u002Fdl\n* Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation.\n* Peptide receptor radionuclide therapy at any time before randomisation\n* Pregnancy and Lactation\n* Patients with concurrent malignancies","ALL","18 Years",{"count":20,"type":21},162,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs. It has demonstrated a significant improvement in outcomes compared to Octreotide LAR, both as a first-line and second-line treatment approach, following the results of NETTER-1 and NETTER-2 trials, respectively. ENETS guidelines recommend the use of Ga-68 labeled DOTANOC\u002FTOC\u002FTATAE imaging only for WHO Grade 1 NET whereas FDG PET is the preferred modality for WHO Grade 3 NEN and NEC. For Grade 2 tumors (Mib index ranging from 3-20%), there are no strong recommendations for the addition of FDG PETCT in existing diagnostic algorithm. FDG PET positivity has been shown to be an independent predictor of shorter progression-free and overall survival in NET patients undergoing peptide receptor radionuclide therapy (PRRT). (8) Consequently, it is imperative to address FDG-avid tumors by integrating PRRT and chemotherapy. There are no strong recommendations for the grade wise management of GEP-NETs particularly grade 2 \\& 3. Although recently published NETTER 2 trial substantiated the role of PRRT as a first line treatment for advanced grade GEP-NETs, still there is lack of evidence supporting the addition of chemotherapy in management of GEP-NETs. Given the absence of a prospective study to establish this treatment regimen, we designed a Phase 3 Randomized Controlled Trial to evaluate the combination of PRRT and CAPE-TEM-based chemotherapy in patients with FDG-positive metastatic well-differentiated NETs.",[27,28,29],"Neuroendocrine Neoplasia's (NENs)","Neuroendocrine Tumor GEP Grade 1-3","Neuroendocrine Gastroenteropancreatic Tumour",[31,32,33,34,35],"Peptide Receptor Radionuclide Therapy","Lu-177 DOTATATE","PRRT","Neuroendocrine tumor","Capecitabine-Temozolamide","RECRUITING","2025-09-17",{"date":39,"type":40},"2025-09-22","ACTUAL",{"date":42,"type":40},"2019-08-07",{"date":44,"type":21},"2027-08-07",{"name":46,"class":47},"Tata Memorial Hospital","OTHER_GOV",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100426813","phase-2-intra-arterial-hepatic-iah-infusion-of-radiolabelled-somatostatin-analogs-in-gep-net-patients-with-dominant-liver-metastases-100426813","NCT04837885","Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases","\"Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases\"","LUTARTERIAL","Inclusion Criteria:\n\n* Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).\n* Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion \\> 50% without waiting for tumour progression\n* Patient has received 4 standard of care LUTATHERA® cycles\n* Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle\n* ECOG performance status 0-2\n* Adequate kidney and liver function: creatinine clearance ≥ 50 mL\u002Fmin, ALT\u002FAST ≤ 2,5x the upper limit of normal\n* With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g\u002FdL, neutrophils ≥ 1500\u002F mm3, platelets ≥ 75.000\u002Fmm3\n* Age ≥ 18 years, no superior limit\n* Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection.\n* Patient´s signed written informed consent\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)\n* No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment\n* Carcinoid heart disease (LVEF \\\u003C 40%)\n* Dominant or threatening extrahepatic metastases or that may affect vital prognosis\n* Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…)\n* Serum albumin \\\u003C30 g\u002FL unless prothrombin time is within the normal range.\n* Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160\u002F95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.\n* Individuals under legal protection or unable of giving their informed consent\n* Pregnancy or breast feeding\n* Currently participating to another clinical research protocol\n* Individuals under legal protection or unable of giving their informed consent\n* MRI scan contraindicated\n* LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose",{"count":57,"type":21},23,[59],"PHASE2","The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).",[62,63,29],"Neuroendocrine Tumor","Liver Metastases",[65,66,63,67,68,31],"Neuroendocrine tumour","Neuroendocrine gastroenteropancreatic (GEP) tumour","68Ga- DOTA-peptides PET CT","177Lutetium-Octreotate","2025-07-18",{"date":71,"type":40},"2025-07-23",{"date":73,"type":40},"2021-09-24",{"date":75,"type":21},"2027-03-24",{"name":77,"class":78},"University Hospital, Bordeaux","OTHER",4]