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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：RAFAEL Loch BATISTA, MD PhD
- 電話番号：+5511992052473
- メール：rafael.loch@hc.fm.usp.br
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Radiological Response Rate to Temozolomide
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TMZ-LATAM-2026-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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