Division of General Surgery, Department of Surgery, University of Ottawa, Ottawa, ON, Canada.
Ann Surg Oncol. 2013 Nov;20(12):3725-31. doi: 10.1245/s10434-013-3054-y. Epub 2013 Jun 26.
The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov.
Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011.
Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%).
The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.
本研究旨在对 ClinicalTrials.gov 上注册的外科肿瘤学临床试验进行描述性分析。
使用以下搜索引擎标准从 ClinicalTrials.gov 提取数据：“癌症”作为条件，“手术或操作或切除术”作为干预措施，非行业赞助。搜索范围限于加拿大和美国，包括 2001 年 1 月 1 日至 2011 年 1 月 1 日期间注册的试验。
在 9961 项肿瘤学试验中，有 1049 项（10.5%）包含任何类型的外科干预措施。在这些试验中，有 125 项（11.9%，占所有肿瘤学试验的 1.3%）评估了手术变量，773 项（73.7%）评估了辅助/新辅助治疗，151 项（14.4%）为观察性研究。在评估辅助治疗的试验中，系统治疗（362 项试验，46.8%）和多模式治疗（129 项试验，16.7%）是主要关注点。在作为干预措施的 125 项手术试验中，59 项（47.2%）侧重于手术技术或设备，45 项（36.0%）研究了侵入性诊断方法，21 项（16.8%）评估了手术与非手术。大多数 125 项试验是非随机的（72 项，占 57.6%）。
与整个肿瘤学试验相比，注册的外科肿瘤学试验数量较少。专门设计用于评估外科干预措施的临床试验远远超过了专注于辅助治疗的试验。随机外科肿瘤学试验占所有注册癌症试验的<1%。需要澄清外科肿瘤学中设计和实施随机试验的障碍，以便为外科决策提供更高水平的证据。
