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

NCT07695844 | Not Yet Recruiting FDA Drug

• 1 other identifier: TMZ-LATAM-2026-1
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Temozolomide; Aggressive Pituitary Tumor; Pituitary Carcinoma; PitNET; MGMT; Latin America; Retrospective Cohort; Multicenter Study

Outcome Measures

Primary Outcomes (2)

• Radiological Response Rate to Temozolomide

  From initiation of temozolomide treatment to best radiological response observed, assessed up to 5 years

• Radiological response

  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

Study Arms (1)

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.

Drug: temozolamide

Interventions

Temozolamide DRUG

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

Temozolomide-Treated Patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Central Study Contacts

RAFAEL Loch BATISTA, MD PhD

CONTACT

+5511992052473; rafael.loch@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Scientist

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 10, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07