[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumor-gep-grade-1-3\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumor-gep-grade-1-3":28},{"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":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100591517","life-following-excision-of-neuroendocrine-tumors-100591517","NCT06981455","Life Following Excision of Neuroendocrine Tumors","LIFE-NETs (Life Following Excision of Neuroendocrine Tumors): a Multi-institutional Prospective Observational Cohort Study of Quality of Life After Surgery for Neuroendocrine Tumors","LIFENETS","Inclusion Criteria:\n\n* Age \\>18 years old\n* Diagnosis of well-differentiated grade 1 to 3 NETs via histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on SSTR-PET scan).\n* Consents to surgery for resection of localized, loco-regional, or metastatic gastro-enteric (midgut) and pancreatic neuroendocrine tumor (GEP-NET).\n\nExclusion Criteria:\n\n* Pre-operative diagnosis of neuroendocrine carcinoma on histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on FDG-PET scan and no avidity on SSTR-PET scan).\n* Declines surgery.\n* Unable to respond to study questionnaires (not proficient in local language).",{"count":57,"type":21},246,"OBSERVATIONAL","Neuroendocrine tumors (NETs), often seen as \"chronic cancer\" present a survival paradox with relatively prolonged patient survival despite active disease. Treatment strategies emphasize management over cure, integrating tumor control with quality of life (QOL) considerations. Surgery is a cornerstone of NET management but demands a careful balance between its potential benefits and the morbidity risks. Current literature on post-surgical QOL is limited and non-generalizable, underscoring the need for comprehensive, multi-institutional data to inform surgical decisions.\n\nWe will study QOL after surgery for NETs in a prospective multi-institutional international cohort study. Specifically, we aim to 1) describe the post-operative QOL of patients with NETs and 2) identify factors associated with QOL measures after surgery for NETs. This project will be led in partnership by the Susan Leslie Clinic for NETs at Sunnybrook Health Sciences Centre in Toronto, Canada, and the IRCCS San Raffaele ENETS Centre of Excellent in Milan, Italy, and enrol adults undergoing surgery for resection of gastro-entero-pancreatic NETs across 12 North-American and European high-volume NETs surgery centres over a 18-month period. Measures of QOL using the SF-12 Survey, the EORTC-QLQ C30 and GEPNET21 tool, and clinical symptoms assessment, will be captured prior to surgery and at 6, 12, 24, and 36 months after surgery. Mixed linear regression models with random intercepts to account for longitudinal data correlation and individual variability will be used to analyze the QOL measures over time. Patient and service users engagement (PSUE) will be integrated throughout the study continuum.\n\nThis project will fill the knowledge gap in QOL after surgery for NETs, with a view to support better-informed surgical decisions and patient-centred care. The prospective, multi-institutional, and international design promises a comprehensive understanding of the impact of surgery on patient's lives, potentially shaping management pathways globally.",[61,28],"Neuroendocrine (NE) Tumors",[63,64,65,66],"surgery","quality of life","carcinoid","neuroendocrine","2025-05-13",{"date":69,"type":40},"2025-05-20",{"date":71,"type":40},"2025-04-28",{"date":73,"type":21},"2028-12-31",{"name":75,"class":76},"Sunnybrook Health Sciences Centre","OTHER",1]