预防:立即新辅助灌注化疗预防非肌性浸润性膀胱癌复发:一项前瞻性随机临床试验方案

Diego M. Carrion, Juan Gómez Rivas, Cristina Ballesteros Ruiz, Mario Alvarez-Maestro, Alfredo Aguilera Bazán, Luis Martínez-Piñeiro
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引用次数: 0

摘要

介绍和目的非肌性浸润性膀胱癌(NMIBC)患者在经尿道膀胱肿瘤切除术(TURBT)后的第一年复发率可高达60%。目前,建议术后立即注入化疗(IPOIC),以预防低至中等风险疾病患者的复发。虽然在实际的临床实践中,这种特定的灌注化疗存在许多难以规范的困难,包括其禁忌症(怀疑或证实膀胱穿孔,广泛或广泛切除,持续膀胱冲洗要求),这只能使其在30%左右的患者中可行。在这项对照研究中,我们建议立即给予新辅助灌注化疗(INAIC),这在技术上适用于所有患者,无论手术结果如何,并与对照组进行比较。我们期望在实验组中发现复发率至少降低15%。方法设计一项IV期、随机、对照、开放标签临床试验。主要入选标准为:临床诊断为局限性乳头状型膀胱癌(疑似低至中危)且无病时间间隔至少6个月的患者。符合条件的患者将被分配到A组(INAIC + TURBT)或B组(TURBT),使用计算机生成的块随机化顺序/比例为1:1。两组的复发时间将使用Kaplan-Meier估计、log-rank检验和cox回归进行分析和比较。将进行单因素和多因素分析,以确定影响复发的因素。这项研究已经得到了La Paz大学医院药物研究伦理委员会(CEIm)和西班牙药品和保健品管理局的批准。
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Precave: Immediate neoadjuvant instillation of chemotherapy for the prevention of non-muscle invasive bladder carcinoma recurrence: A prospective randomized clinical trial protocol

Introduction and objectives

Recurrence rates for patients presenting with non-muscle invasive bladder carcinoma (NMIBC) can be as high as 60% during the first year after a transurethral resection of bladder tumor (TURBT). Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease. Although in real clinical practice this specific instillation of chemotherapy has many difficulties to be standardized, including its contraindications (suspected or confirmed bladder perforation, wide or extensive resection and, continuous bladder irrigation requirement), which will only make it feasible for around 30% of patients.

We propose in this controlled study, to administer an immediate neoadjuvant instillation of chemotherapy (INAIC), which can be applied technically to all patients, no matter the surgical outcomes and compare it with a control group. We expect to find a reduction in the recurrence rate in the experimental group of at least 15%.

Methods

We designed a phase IV, randomized, controlled, open label clinical trial. Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6 months. Eligible patients will be allocated into group A (INAIC plus TURBT) or group B (TURBT) using a computer-generated block randomization sequence/ratio 1:1. Time to recurrence of both groups will be analyzed and compared using Kaplan-Meier estimates, log-rank tests and, Cox-regression. Univariate and multivariate analyzes will be performed to determine factors which influence recurrence. The study has received the approval of the Ethics Committee for Drug Research (CEIm) of La Paz University Hospital and the Spanish Agency for Medicines and Health Products.

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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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