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

4. juli 2026 oppdatert av: RAFAEL LOCH BATISTA, University of Sao Paulo General Hospital

TEMPLA: TEMozolomide in Pituitary Tumors - Latin America - A Multicenter Retrospective Cohort of Temozolomide Therapy in Aggressive Pituitary Neuroendocrine Tumors and Pituitary Carcinomas

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of patients diagnosed with aggressive pituitary neuroendocrine tumors (PitNETs) or pituitary carcinomas who were treated with temozolomide as part of routine clinical management at participating centers across Latin America, including a previously established Brazilian multicenter cohort. Patients were identified retrospectively through review of institutional pathology, oncology, and endocrinology records. The population reflects real-world clinical practice, encompassing diverse tumor subtypes (functioning and non-functioning PitNETs) and variable temozolomide dosing protocols, rather than a population selected under a standardized experimental treatment regimen.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Radiological Response Rate to Temozolomide
Tidsramme: From initiation of temozolomide treatment to best radiological response observed, assessed up to 5 years
From initiation of temozolomide treatment to best radiological response observed, assessed up to 5 years
Radiological response
Tidsramme: From initiation of temozolomide treatment to radiological or clinical disease progression, or death from any cause, whichever occurs first, assessed up to 5 years
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.
From initiation of temozolomide treatment to radiological or clinical disease progression, or death from any cause, whichever occurs first, assessed up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

10. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

4. juli 2026

Først innsendt som oppfylte QC-kriteriene

4. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TMZ-LATAM-2026-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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