[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-neoplasias-nens\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-neoplasias-nens":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":48},"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",2]