Characteristics of stereotactic radiotherapy clinical trials registered on ClinicalTrials.gov.

BACKGROUND: 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. METHODS: 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. RESULTS: 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Institutes of Health (NIH), respectively. 15.4% stopped early with status includes "suspended", "terminated" and "withdrawn".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% vs. 34.4%; P=0.001), with 2 study arms (27.1% vs. 42.1%; P=0.002), industry-funded (11.0% vs. 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% vs. 6.1% for Europe and 6.5% for Asia, P<0.001), nonrandomized (77.7% vs. 56.8% for Europe and 64.1% for Asia, P<0.001). Trials from Asia were more likely to have recruiting status (56.5% vs. 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. CONCLUSIONS: 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.

A parameterized model for mean urinary inflow rate and its preliminary application in radiotherapy for cervical cancer.

Forty-nine patients with stage IIb cervical cancer were included to investigate the changes in bladder volume in response to different approaches to maintaining consistent bladder filling. The impacts of age (P age), water consumption (P wat ), and body mass index (BMI, P bmi ) on the mean urinary inflow rate (v tot ) were analysed. The bladder volume (BV) increased linearly over time. A large variation in v tot among individuals was observed, ranging from 0.19 to 5.13 ml/min. The v tot was correlated with P age (R = -0.53, p = 0.01) and P wat (R = 0.84, p = 0.00), and no correlation between v tot and P bmi was found (p > 0.05). Therefore, v tot could be parameterized using two methods: multivariable linear regression and iterative fitting. There was no statistically significant difference between the two methods. The model accuracy was successfully assessed with several validation tests for patients with good compliance (79.2% of all patients), and the proportion of radiotherapy (RT) fractions with zero wait time (one ultrasound (US) scan) increased from 6.5% to 41.2%. The optimal US scanning number and RT time could be provided using this model. This adaptive RT approach could reduce patient discomfort caused by holding onto urine and reduce technician labour as well as cost.

[Efficacy of Yanshu injection (a compound Chinese traditional medicine) combined with concurrent radiochemotherapy in patients with stage III nasopharyngeal carcinoma].

OBJECTIVE: To evaluate the efficacy and toxicity of Yanshu injection (a compound Chinese traditional medicine from Sophora flauescens Ait) combined with concomitant radiochemotherapy in patients with stage III nasopharyngeal carcinoma. METHODS: Sixty patients with stage III nasopharyngeal carcinoma were randomized into Yanshu group and control group (n = 30, each). Patients in the Yanshu group received Yanshu injection in addition to intensity modulated radiation therapy (IMRT) and concomitant chemotherapy, and those in the control group were treated with IMRT and concurrent chemotherapy. RESULTS: The 1-year, 2-year, 3-year and 4-year overall survival rates were 100%, 93.3%, 86.7%, 80.0% for Yanshu group, and 96.7%, 90.0%, 83.3%, 76.7% for the control group, respectively, with no significant difference between the two groups (P = 0.565). The 1-year, 2-year, 3-year and 4-year progression-free survival rates were 96.7%, 90.0%, 83.3%, 70.0% for Yanshu group, and 90.0%, 86.7%, 76.7%, 66.7% for control group, respectively, with no significant difference (P = 0.554). However, the reaction of mucosa of oral cavity, myelosuppression and thrombocytopenia in the Yanshu group were significantly lower than that in the control group (P < 0.05). The quality of life of the patients in the Yanshu group was significantly higher than that in the control group (P < 0.05). CONCLUSIONS: Yanshu injection combined with radiochemotherapy in patients with stage III nasopharyngeal carcinoma show a good efficacy and can reduce the side effects of radiochemotherapy of nasopharygeal carcinoma, and improve the quality of life of the patients.