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Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS) (GUARDIANS)

2026年10月1日更新者：Can Aydogdu, MD、LMU Klinikum

Perioperative GUARDIANS Project: Real-World Evaluation of Feasibility, Toxicity, and Oncologic Outcomes of Perioperative Systemic Therapies in Muscle-Invasive Urothelial Carcinoma

This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. The registry includes patients treated with perioperative systemic therapies such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based combinations including Gemcitabine/Cisplatin/Durvalumab and other standard perioperative treatment approaches in the neoadjuvant and adjuvant setting.

The study aims to evaluate real-world feasibility, treatment tolerability, pathologic response, and oncologic outcomes of perioperative systemic treatment strategies. Key outcomes include event-free survival (EFS), pathologic complete response (pCR), pathologic downstaging, disease-free survival (DFS), overall survival (OS), perioperative complications, and treatment-related adverse events. Patient-reported neurotoxicity symptoms will also be assessed using standardized neuropathy questionnaires.

All treatments, surgeries, and follow-up procedures are performed according to routine clinical practice. No study-specific interventions are assigned. Clinical data are collected pseudonymized through participating GUARDIANS centers using standardized electronic case report forms. Both prospective and retrospective data collection are included.

調査の概要

状態

募集

条件

介入・治療

他の：Perioperative Systemic Therapy Registry

詳細な説明

The GUARDIANS perioperative registry is a multicenter observational study designed to collect real-world data on perioperative systemic therapies in patients with muscle-invasive or locally advanced urothelial carcinoma of the bladder.

Perioperative systemic treatment strategies for muscle-invasive bladder cancer are rapidly evolving and include antibody-drug conjugate-based combinations such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based regimens including Gemcitabine/Cisplatin/Durvalumab and other standard neoadjuvant and adjuvant treatment approaches. While these regimens are increasingly used in routine care, systematic real-world evidence regarding feasibility, dose intensity, perioperative safety, patient-reported neurotoxicity, pathologic response, and long-term oncologic outcomes remains limited.

This registry evaluates perioperative treatment strategies with particular focus on real-world implementation, treatment completion, and comparative outcomes across different systemic therapy approaches. Patients are followed longitudinally from baseline and diagnosis through neoadjuvant therapy, radical cystectomy with pelvic lymph node dissection, adjuvant therapy when applicable, and long-term follow-up.

The primary objective is evaluation of event-free survival (EFS) and treatment feasibility. Feasibility includes completion of intended radical cystectomy, delivery of planned neoadjuvant and adjuvant treatment components, and reasons for treatment delay, modification, or discontinuation.

Secondary objectives include assessment of:

Pathologic complete response (pCR, ypT0N0) Pathologic downstaging Disease-free survival (DFS) Overall survival (OS) Local and distant recurrence patterns 90-day postoperative complications after radical cystectomy CTCAE version 5.0 treatment-related toxicities Patient-reported chemotherapy-induced peripheral neuropathy symptoms Treatment exposure and dose intensity The study is non-interventional. All diagnostic and therapeutic decisions are made independently of study participation according to local standard of care. No additional mandatory visits, diagnostic procedures, or therapeutic interventions are required.

Data are collected pseudonymized using REDCap across participating GUARDIANS centers. Prospective collection includes patient-reported outcome measures for neurotoxicity, while retrospective collection allows inclusion of previously treated patients according to ethics approval and local regulations. The registry supports evaluation of real-world outcomes across multiple perioperative treatment strategies and provides comparative evidence for routine clinical practice.

研究の種類

観察的

入学 (推定)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

ドイツ
- - Munich、ドイツ、81377
    - 募集
    - Department of Urology, LMU University Hospital Munich
    - コンタクト：
      
      Can Aydogdu, MD
      
      電話番号：+49 89 4400 0
      
      メール：can.aydogdu@med.uni-muenchen.de

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients with muscle-invasive or locally advanced urothelial carcinoma of the bladder receiving perioperative systemic therapy in routine clinical practice. Patients are treated in the neoadjuvant and/or adjuvant setting with curative intent and undergo or are planned for radical cystectomy with pelvic lymph node dissection. Treatment approaches include Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, and other standard perioperative systemic therapies. Both prospective and retrospective patients from participating GUARDIANS centers are included.

説明

Inclusion Criteria:

Age ≥18 years
Histologically confirmed muscle-invasive or locally advanced urothelial carcinoma of the bladder
Planned, ongoing, or completed perioperative systemic therapy, including but not limited to Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, or other standard perioperative treatment approaches
Radical cystectomy planned or performed as part of curative-intent treatment strategy
Written informed consent for prospective data collection, where required
Sufficient clinical documentation available for retrospective inclusion, including at least one follow-up assessment

Exclusion Criteria:

Missing informed consent where prospectively required
Insufficient documentation of key baseline data or treatment exposure
No perioperative systemic therapy or inability to assign patient to a study cohort
Follow-up data unavailable or inconsistent documentation preventing endpoint assessment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：COHORT
時間の展望：PROSPECTIVE

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	時間枠
Event Free Survival (EFS) 時間枠：From treatment initiation up to 36 months	From treatment initiation up to 36 months

二次結果の測定

結果測定	メジャーの説明	時間枠
Pathologic Complete Response (pCR) 時間枠：At radical cystectomy		At radical cystectomy
Pathologic Downstaging 時間枠：At radical cystectomy	Defined as less than ypT2N0 in the cystectomy specimen, including pT0, pTis, pTa, and pT1.	At radical cystectomy
Disease-Free Survival (DFS) 時間枠：Up to 36 months after surgery	Time from curative surgery until recurrence or death.	Up to 36 months after surgery
Overall Survival (OS) 時間枠：Up to 60 months	Time from treatment initiation until death from any cause.	Up to 60 months
Change Over Time in Patient-Reported Peripheral Neuropathy Assessed by the EORTC QLQ-CIPN20 時間枠：Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and end of treatment ±14 days	Patient-reported peripheral neuropathy symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20). The questionnaire assesses sensory, motor, and autonomic symptoms of peripheral neuropathy. Subscale scores are calculated according to the EORTC scoring procedure and linearly transformed to a scale ranging from 0 to 100. Higher scores indicate greater peripheral neuropathy symptom burden and therefore a worse outcome. Changes from baseline will be assessed longitudinally during perioperative treatment through end of treatment.	Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and end of treatment ±14 days
Treatment-Related Adverse Events 時間枠：From first administration of neoadjuvant therapy through the end-of-treatment visit, up to approximately 12 months	Occurrence, type, severity, attribution, management, and outcome of treatment-related adverse events associated with perioperative enfortumab vedotin and pembrolizumab. Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.	From first administration of neoadjuvant therapy through the end-of-treatment visit, up to approximately 12 months
90-Day Postoperative Complications 時間枠：Up to 90 days after radical cystectomy	Occurrence and severity of postoperative complications within 90 days after radical cystectomy, graded according to the Clavien-Dindo classification.	Up to 90 days after radical cystectomy
90-Day Perioperative Mortality 時間枠：Up to 90 days after radical cystectomy	All-cause mortality occurring within 90 days after radical cystectomy following perioperative systemic therapy. This includes deaths related to surgical complications, treatment-related toxicity, or other causes during the perioperative period.	Up to 90 days after radical cystectomy

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

LMU Klinikum

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月17日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2029年5月31日

試験登録日

最初に提出

2026年5月17日

QC基準を満たした最初の提出物

2026年10月1日

最初の投稿 (実際)

2026年10月2日

学習記録の更新

投稿された最後の更新 (実際)