[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646138":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":10,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Temozolomide-Treated Patients",null,"Patients with histologically confirmed aggressive pituitary neuroendocrine tumor (PitNET) or pituitary carcinoma who received temozolomide chemotherapy as part of clinical management, following disease progression despite standard therapy (surgery and\u002For radiotherapy). Data on temozolomide dose, treatment duration, and radiological response were retrospectively collected from participating Latin American centers. No intervention was assigned as part of this study; temozolomide was administered as standard clinical care prior to data collection.",[13],"Drug: temozolamide",[15,20],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","temozolamide","Temozolomide, an oral alkylating chemotherapeutic agent, administered as part of routine clinical management for aggressive pituitary neuroendocrine tumors (PitNETs) and pituitary carcinomas refractory to standard therapy. Dosing regimens, cycle duration, and total number of cycles varied according to each treating center's clinical protocol and were not standardized as part of this study. Temozolomide was not assigned by the investigators for research purposes; all treatment decisions were made independently by the treating clinical team prior to data collection",[9],{"type":16,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Temozolamide","Unlike most published temozolomide studies in aggressive pituitary tumors, which are limited to single-center case series from Europe or North America, this cohort captures multicenter, real-world temozolomide use specifically in Latin American patients with aggressive PitNETs and pituitary carcinomas. Data include MGMT status (immunohistochemistry and\u002For promoter methylation) as an exploratory predictor of response, collected under heterogeneous but harmonized dosing protocols reflecting routine clinical practice across participating centers, rather than a standardized experimental regimen.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"RAFAEL Loch BATISTA, MD PhD","CONTACT","+5511992052473","rafael.loch@hc.fm.usp.br",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","RAFAEL LOCH BATISTA","Medical Scientist","100646138","temozolomide-in-aggressive-pituitary-neuroendocrine-tumors-a-latin-american-multicenter-retrospective-cohort-tmz-latam-100646138",false,"NCT07695844","Temozolomide in Aggressive Pituitary Neuroendocrine Tumors: A Latin American Multicenter Retrospective Cohort (TMZ-LATAM)","TEMPLA: TEMozolomide in Pituitary Tumors - Latin America - A Multicenter Retrospective Cohort of Temozolomide Therapy in Aggressive Pituitary Neuroendocrine Tumors and Pituitary Carcinomas","TEMPLA","Inclusion Criteria:\n\nHistologically confirmed pituitary neuroendocrine tumor (PitNET) meeting criteria for aggressive behavior (Knosp grade ≥3, radiological tumor growth \\>20% within 6 months, and\u002For progression despite optimized standard therapy including surgery and\u002For radiotherapy), OR histologically or clinically confirmed pituitary carcinoma (defined by the presence of craniospinal or systemic metastasis) Treatment with temozolomide, at any dose or duration, administered for the above indication Availability of pre-treatment and post-treatment imaging sufficient to assess radiological response Temozolomide treatment initiated within the defined study period\n\nExclusion Criteria:\n\nInsufficient clinical or imaging data to assess the primary outcome measure Temozolomide administered for an indication other than aggressive PitNET or pituitary carcinoma Loss to follow-up before any post-treatment imaging assessment","ALL",{"count":44,"type":45},80,"ESTIMATED","OBSERVATIONAL","Temozolomide is the main chemotherapy drug used for aggressive pituitary tumors and pituitary carcinomas that do not respond to standard treatments like surgery or radiation. Most of what is known about how well this treatment works comes from small studies in Europe and the United States, with very little data from Latin America. Building on a previous multicenter study conducted in Brazil, this study (TEMPLA) expands data collection to additional centers across Latin America to better understand how patients in this region respond to temozolomide, how long the treatment controls the tumor, and whether certain tumor characteristics (such as MGMT status) can help predict which patients are more likely to benefit.",[49],"Pituitary Neoplasms",[51],"Temozolomide; Aggressive Pituitary Tumor; Pituitary Carcinoma; PitNET; MGMT; Latin America; Retrospective Cohort; Multicenter Study","NOT_YET_RECRUITING","2026-07-04",{"date":55,"type":56},"2026-07-10","ACTUAL",{"date":58,"type":45},"2026-08-01",{"date":60,"type":45},"2028-12-31",{"name":5,"class":6}]