Zhang Xin, Yang Ding-Yi, Wang Can, Huang Luo
Department of Radiation Oncology, Chongqing University Cancer Hospital, Chongqing, China.
Transl Cancer Res. 2021 Oct;10(10):4316-4326. doi: 10.21037/tcr-21-1189.
We aim to analyze the characteristics of stereotactic radiotherapy trials registered on ClinicalTrials.gov, and to compare completed and stopped early trials to identify predictors of trial failure.
All interventional stereotactic radiotherapy trials registered on ClinicalTrials.gov before Dec 31, 2019 were downloaded. Trial characteristics over time and between different regions were compared by Chi-square test. Binary logistic regression was used to explore characteristics associated with trials stopped early.
A total of 760 trials were included. A higher proportion of trials were about lung cancer (20.4%), prostate cancer (14.7%) and central nervous system (14.6%). Most trials were phase1 and/or 2 trials (63.0%), single group (62.4%), nonrandomized (71.7%), open-label (95.0%) and single center (75.8%). The median sample size was 40 (0-1,716). Only 15.1% and 13.5% were funded by industry and National Institutes of Health (NIH), respectively. 15.4% stopped early with status includes "suspended", "terminated" and "withdrawn". Of the 113 "completed" trials, only 28 were published on PubMed. Compared with 2010 to 2014, trials from 2015 to 2019 were more likely to be randomized (20.0% 34.4%; P=0.001), with 2 study arms (27.1% 42.1%; P=0.002), industry-funded (11.0% 19.1%; P=0.028) and conducted in Asia (7.6% to 15.8%; P=0.002). Trials from North America were more oriented toward phase 1 research (24.4% 6.1% for Europe and 6.5% for Asia, P<0.001), nonrandomized (77.7% 56.8% for Europe and 64.1% for Asia, P<0.001). Trials from Asia were more likely to have recruiting status (56.5% 45.5% for Europe and 43.6% for North America, P<0.001). Multivariate regression analysis showed that randomized (OR 8.090, P=0.001), and enrollment patients ≤50 (OR 3.813, P<0.001) were associated with trials stopped early.
Stereotactic radiotherapy trials are predominantly early-phase, small, single arm, nonrandomized and open label. Trials with randomized allocation or enrollment patients ≤50 were more likely to stop early.
我们旨在分析在ClinicalTrials.gov上注册的立体定向放射治疗试验的特征，并比较已完成和提前终止的试验，以确定试验失败的预测因素。
下载2019年12月31日前在ClinicalTrials.gov上注册的所有介入性立体定向放射治疗试验。通过卡方检验比较不同时间和不同地区的试验特征。采用二元逻辑回归探索与提前终止试验相关的特征。
共纳入760项试验。较高比例的试验涉及肺癌（20.4%）、前列腺癌（14.7%）和中枢神经系统（14.6%）。大多数试验为1期和/或2期试验（63.0%）、单组试验（62.4%）、非随机试验（71.7%）、开放标签试验（95.0%）和单中心试验（75.8%）。样本量中位数为40（0 - 1716）。分别只有15.1%和13.5%由行业和美国国立卫生研究院（NIH）资助。15.4%提前终止，状态包括“暂停”“终止”和“撤回”。在113项“完成”的试验中，只有28项发表在PubMed上。与2010年至2014年相比，2015年至2019年的试验更可能是随机的（20.0%对34.4%；P = 0.001），有2个研究组（27.1%对42.1%；P = 0.002），由行业资助（11.0%对19.1%；P = 0.028）且在亚洲进行（7.6%至15.8%；P = 0.002）。北美地区的试验更倾向于1期研究（欧洲为24.4%，亚洲为6.1%和6.5%，P < 0.001），非随机试验（欧洲为77.7%，亚洲为56.8%和64.1%，P < 0.001）。亚洲地区的试验更可能处于招募状态（欧洲为45.5%，北美为43.6%，P < 0.001）。多变量回归分析显示，随机试验（OR 8.090，P = 0.001）和入组患者≤50例（OR 3.813，P < 0.001）与提前终止试验相关。
立体定向放射治疗试验主要为早期、小规模、单组、非随机和开放标签试验。采用随机分配或入组患者≤50例的试验更可能提前终止。
