Temozolomide in Aggressive Pituitary Neuroendocrine Tumors: A Latin American Multicenter Retrospective Cohort (TMZ-LATAM) (TEMPLA)
TEMPLA: TEMozolomide in Pituitary Tumors - Latin America - A Multicenter Retrospective Cohort of Temozolomide Therapy in Aggressive Pituitary Neuroendocrine Tumors and Pituitary Carcinomas
Descripción general del estudio
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Condiciones
Intervención / Tratamiento
Descripción detallada
Temozolomide is the first-line chemotherapeutic agent recommended for aggressive pituitary neuroendocrine tumors (PitNETs) and pituitary carcinomas refractory to standard therapy, including surgery and radiotherapy. Current evidence supporting its use derives largely from small case series and single-country cohorts, with limited data representative of Latin American populations.
TEMPLA (TEMozolomide in Pituitary tumors - Latin America) is a retrospective, multicenter cohort study that expands a previously conducted national Brazilian cohort on temozolomide use in aggressive PitNETs and pituitary carcinomas to a broader Latin American regional scope. Participating centers will retrospectively identify patients treated with temozolomide for histologically confirmed aggressive PitNET (defined by Knosp grade ≥3, radiological growth >20% within 6 months, and/or progression despite optimized standard therapy) or histologically/clinically confirmed pituitary carcinoma.
Data will be collected via a standardized electronic case report form (REDCap), with harmonized diagnostic and response criteria applied across all participating sites to minimize inter-center heterogeneity. Mandatory variables include tumor subtype and lineage, temozolomide dose and treatment duration, and radiological response assessed from pre- and post-treatment imaging. MGMT status (by immunohistochemistry and/or promoter methylation analysis, where locally available) will be collected as a secondary variable and analyzed as an exploratory predictor of treatment response.
The primary aim of this study is to characterize the radiological response rate to temozolomide across Latin American centers. Secondary aims include estimating progression-free survival and overall survival following temozolomide initiation, evaluating the association between MGMT status and treatment response, and describing treatment-related adverse events.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: RAFAEL Loch BATISTA, MD PhD
- Número de teléfono: +5511992052473
- Correo electrónico: rafael.loch@hc.fm.usp.br
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Histologically confirmed pituitary neuroendocrine tumor (PitNET) meeting criteria for aggressive behavior (Knosp grade ≥3, radiological tumor growth >20% within 6 months, and/or progression despite optimized standard therapy including surgery and/or 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
Exclusion Criteria:
Insufficient 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Temozolomide-Treated Patients
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/or 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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Radiological Response Rate to Temozolomide
Periodo de tiempo: From initiation of temozolomide treatment to best radiological response observed, assessed up to 5 years
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From initiation of temozolomide treatment to best radiological response observed, assessed up to 5 years
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Radiological response
Periodo de tiempo: From initiation of temozolomide treatment to radiological or clinical disease progression, or death from any cause, whichever occurs first, assessed up to 5 years
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Radiological response to temozolomide will be classified as complete response, partial response, stable disease, or progressive disease, based on comparison of pre-treatment and post-treatment imaging (MRI) available for each patient.
Response classification will follow criteria adapted from RECIST where applicable, acknowledging that formal RECIST assessment may not have been systematically applied at the time of clinical treatment in all participating centers.
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From initiation of temozolomide treatment to radiological or clinical disease progression, or death from any cause, whichever occurs first, assessed up to 5 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por sitio
- Neoplasias
- Neoplasias de glándulas endocrinas
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Enfermedades hipotalámicas
- Neoplasias hipotalámicas
- Neoplasias Supratentoriales
- Neoplasias Cerebrales
- Enfermedades de la pituitaria
- Neoplasias hipofisarias
Otros números de identificación del estudio
- TMZ-LATAM-2026-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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