[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607216":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":79,"collaborators":82,"id":83,"slug":82,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":82,"enrollmentInfo":92,"targetDuration":82,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":53,"whyStopped":82,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Tata Memorial Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE","ACTIVE_COMPARATOR","Patient in this arm will be treated only with 4 cycles of PRRT",[13],"Radiation: Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE",{"label":15,"type":16,"description":17,"interventionNames":18},"PRRT with Lu-177 DOTATATE PLUS Capecitabine-Temozolamide","EXPERIMENTAL","Patient in this arm will be treated with combination of PRRT and Chemotherapy",[13,19],"Drug: Capecitabine plus temozolamide",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Radionuclide Therapy",[15,9],[26],"PRRT",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Capecitabine plus temozolamide","Chemotherapy",[15],[33],"CAPE-TEM",[35],{"name":36,"affiliation":37,"role":38},"Ameya Puranik, MD","Professor and Consultant","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Sushil K Yadav, MSc","CONTACT","912224177000","7019","sushilyadav.crc@gmail.com",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Farkhanda K Khan, MSc","7150","khanfarkhanda1998@gmail.com",[51,67],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Tata Memorial Hospital, Mumbai, India","RECRUITING","Mumbai","Maharashtra","400012","India",{"type":59,"coordinates":60},"Point",[61,62],72.88261,19.07283,{"lat":62,"lon":61},[65],{"name":66,"role":42,"phone":43,"phoneExt":44,"email":45},"Sushil Yadav",{"facility":68,"status":53,"city":69,"state":55,"zip":70,"country":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)","Navi Mumbai","410210",{"type":59,"coordinates":72},[73,74],73.01582,19.03681,{"lat":74,"lon":73},[77],{"name":66,"role":42,"phone":43,"phoneExt":78,"email":45},"7151",{"type":38,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":82,"oldOrganization":82},"Ameya Puranik","Professor",null,"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":93,"type":94},162,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100,101,102],"Neuroendocrine Neoplasia's (NENs)","Neuroendocrine Tumor GEP Grade 1-3","Neuroendocrine Gastroenteropancreatic Tumour",[104,105,26,106,107],"Peptide Receptor Radionuclide Therapy","Lu-177 DOTATATE","Neuroendocrine tumor","Capecitabine-Temozolamide","2025-09-17",{"date":110,"type":111},"2025-09-22","ACTUAL",{"date":113,"type":111},"2019-08-07",{"date":115,"type":94},"2027-08-07",{"name":5,"class":6},2]