[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumor-grade-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumor-grade-2":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,68,99,126],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100388530","phase-2-captemy90-for-grade-23-net-liver-metastases-100388530",false,"NCT04339036","CapTemY90 for Grade 2\u002F3 NET Liver Metastases","UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2\u002F3 Neuroendocrine Tumors","CapTemY90","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)\n* Patients with at least one measurable liver metastases, with size \\> 1cm (RECIST criteria)\n* Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver\n* Liver tumor burden does not exceed 50% of the liver volume\n* Patent main portal vein\n* At least 4 weeks since last administration of last chemotherapy and \u002For radiotherapy\n* Age \\>18 years.\n* Life expectancy of greater than 6 months.\n* ECOG performance status 0-2.\n* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg\u002Fdl, ALT, AST ≤5 times ULN, albumin ≥2.5g\u002Fdl.\n* Patients must have adequate organ and marrow function as defined below:\n* platelets \\>100,000\u002FmcL (may be corrected by transfusion)\n* serum creatinine \\\u003C 2.0 mg\u002Fdl\n* INR \\\u003C1.6, (may be corrected by transfusion)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)\n\nExclusion Criteria:\n\n* Contraindications to capecitibine or temozolomide\n* Contraindicated for both contrast-enhanced MRI and CT\n* Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)\n* Contraindication for radioembolization procedures:\n* excessive hepatopulmonary shunt as determined by the investigator\n* inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures\n* Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.\n* Patients may not be receiving any other investigational agents.\n* Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).\n* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and lactating women are ineligible","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.\n\nA Grade 3 arm was added in 2025.",[27,28],"Neuroendocrine Tumor Grade 2","Neuroendocrine Tumors","RECRUITING","2026-06-02",{"date":32,"type":33},"2026-06-04","ACTUAL",{"date":35,"type":33},"2021-10-07",{"date":37,"type":21},"2028-07-01",{"name":39,"class":40},"Abramson Cancer Center at Penn Medicine","OTHER",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100546474","phase-2-177lu-dotatate-modified-delivery-based-on-individualized-dosimetry-100546474","NCT06395402","177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry","LUMOD-ID","In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs, concomitant medication review, and medical history must be completed within 60 calendar days to confirm appropriateness of Lutathera treatment as well as to foundation for listed criteria.\n\nInclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Aged ≥ 18 years at time of consent.\n* Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)\n* Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake \\> liver background on sstr2 PET\u002FCT with any FDA approved sstr2 imaging agent. SSTR2 PET\u002FCT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.\n* Recommended to receive LUTATHERA® therapy for unresectable and\u002For metastatic neuroendocrine disease.\n* Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).\n* Agrees to contraception during therapy.\n* Neutrophil count within normal limits within 28 days of treatment day 1.\n* Platelet count within normal limits within 28 days of treatment day 1.\n* Ability to take oral medication and be willing to adhere to the treatment regimen\n* For individuals of reproductive potential: agreement to use effective birth control\n* Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood sample; minimize social interactions during low blood counts.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \\& dump' strategy; lactation must be discontinued).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).\n* Prior peptide-receptor radiotherapy (PRRT).\n* Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).\n* A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound\u002Fnegatively impact study objectives (documentation of the rationale must be provided)\n* Prior external beam radiation dose to the kidneys of \\>10 Gy (mean dose to functional renal volume).\n* Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.",{"count":50,"type":21},120,[24],"The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will:\n\n* Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET\u002FCT scan\n* Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry)\n* Undergo blood tests for 4 to 8 weeks after each Lutathera treatment\n* Complete patient reported outcome questionnaires\n* Visit the clinic for follow-up about every 8 weeks.",[28,54,27],"Neuroendocrine Tumor Grade 1",[56,57],"lutetium Lu 177 dotatate","Radiotherapy Planning, Computer-Assisted","2025-07-17",{"date":60,"type":33},"2025-07-22",{"date":62,"type":33},"2024-05-03",{"date":64,"type":21},"2029-12-31",{"name":66,"class":40},"University of Iowa",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":67},"100398130","rediscovering-biomarkers-for-the-diagnosis-and-early-treatment-response-in-nen-reborn-100398130","NCT04464122","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study","REBORN","Inclusion Criteria:\n\n* Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group);\n* Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group).\n\nExclusion Criteria:\n\n* Severe chronic kidney disease (stage 4-5);\n* Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;\n* Other non-neuroendocrine malignancies.","80 Years",{"count":78,"type":21},60,"OBSERVATIONAL","This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.",[28,82,54,27,83],"Neuroendocrine Neoplasm","Neuroendocrine Carcinoma",[85,86,87,88,89],"Neuroendocrine Tumours","Prognostic markers","Tumour educated platelets","angiogenesis","immune function","2025-03-31",{"date":92,"type":33},"2025-04-03",{"date":94,"type":33},"2020-09-14",{"date":96,"type":21},"2025-12-31",{"name":98,"class":40},"University of Roma La Sapienza",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":67},"100581806","phase-2-absorbed-tumor-dose-in-peptide-receptor-radionuclide-therapy-with-long-acting-somatostatin-analogues---atsa-trial-100581806","NCT06855095","Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial","ATSA","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Able to provide spoken and written informed consent for the trial;\n* Histopathological confirmed neuroendocrine tumor;\n* Fulfill the clinical criteria for PRRT;\n* At least one soft tissue lesion \\> 2 cm;\n* Aimed administered activity of 7400 MBq;\n* ECOG score (performance status) 0-2.\n\nExclusion Criteria:\n\n* Not possible to discontinue LA-SSA for 4-6 weeks;\n* Use of short-acting SSAs;\n* Pregnancy and lactating female patients;\n* Inability to comply to the study procedures;\n* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).",{"count":107,"type":21},39,[24,109],"PHASE3","According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.",[28,54,27,82],[113,114,115,116],"Peptide Receptor Radionuclide Therapy","PRRT","Lutetium","DOTATATE","2025-02-26",{"date":119,"type":33},"2025-03-03",{"date":121,"type":33},"2024-06-25",{"date":123,"type":21},"2027-03-01",{"name":125,"class":40},"The Netherlands Cancer Institute",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100552384","phase-2-everolimus-5-mg-vs-10-mgdaily-for-patients-with-neuroendocrine-tumors-100552384","NCT06472388","Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Neuroendocrine Tumors","Randomized Phase II Trial of Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Advanced Neuroendocrine Tumors","EVENET","Inclusion Criteria:\n\n* Histological confirmation of well-differentiated Grade 1\u002FGrade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.\n* Metastatic or locally advanced and unresectable disease, measurable by images\n* Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators\n* At least one previous line of systemic treatment (suspended for more than 3 weeks).\n* Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:\n\n  * Hemoglobin \\> 8 g\u002FdL\n  * Neutrophils ≥ 1,500\u002Fmm³\n  * Platelets \\> 90,000\u002Fmm³\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \\[upper limit of normal\\] or ≤ 5 x ULN for patients with liver metastases\n  * Bilirubin ≤ 1.5 x ULN, creatinine \\\u003C 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Aggressive disease requiring cytotoxic therapy\n* Severe\u002Funcontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.\n* MiNEN","16 Years",{"count":136,"type":21},100,[24],"Everolimus is approved in many countries to treat patients with advanced\u002Fmetastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg\u002Fday\u002Fweek was sufficient to inhibit cell proliferation by blocking the mTOR pathway.\n\nThis is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral\u002Fdaily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.",[28,140,54,27,141,142,143],"Progression","Neuroendocrine Tumor of Pancreas","Neuroendocrine Tumor of the Lung","Neuroendocrine Tumor Carcinoid","2024-06-18",{"date":121,"type":33},{"date":147,"type":33},"2024-04-24",{"date":149,"type":21},"2026-12-31",{"name":151,"class":40},"AC Camargo Cancer Center",2]