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Temozolomide in Aggressive Pituitary Neuroendocrine Tumors: A Latin American Multicenter Retrospective Cohort (TMZ-LATAM)

NCT07695844 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

  • Pituitary Neoplasms

Interventions

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

DRUG

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/or 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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-10
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695844 on ClinicalTrials.gov