Oesophageal squamous cell carcinoma (ESCC) ranks among the most aggressive malignancies and carries a poor prognosis. Lymphocytes play a key role in combating infections and suppressing tumourigenesis. Many studies have established a close association between lymphocyte depletion and adverse therapeutic outcomes in oesophageal cancer. Nevertheless, high-quality data validating the clinical efficacy and safety of lymphocyte-sparing thoracic radiotherapy regimens for ESCC remain scarce.
This prospective, open-label, randomised controlled trial aims to determine whether lympho-nTRT-ESO reduces the incidence of acute grade 3–4 lymphopaenia in patients with ESCC undergoing neoadjuvant chemoradiotherapy (nCRT), compared with conventional thoracic radiotherapy (RT). A total of 212 participants will be enrolled and randomly allocated in a 1:1 ratio to either the lymphocyte-sparing RT (RT) group or the conventional RT group. All patients will receive standardised nCRT, which will deliver a total dose of 41.4 Gy in 23 fractions. For the lymphocyte-sparing RT group, RT planning prioritises the planning target volume (PTV) coverage and conventional organ-at-risk (OAR) constraints while applying dose constraints to lymphocyte-related OARs (LOARs). These LOARs include the T1–T12 vertebral bodies, ribs, spleen and major cardiovascular structures (heart and large blood vessels), with optimisation performed only after PTV coverage and standard OAR constraints are satisfied.
This trial was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (RJ 2024–210) on 11 July 2024 and registered on ClinicalTrials.gov (NCT06596954) before participant recruitment. All participants should provide written informed consent to be eligible. We planed to publish the primary and secondary results of this study in scientific peer-reviewed journals and present at radiation oncology conferences.
This study aimed to comprehensively assess the diagnostic accuracy of point shear wave elastography (pSWE) and vibration-controlled transient elastography (VCTE) in paediatric metabolic dysfunction-associated steatotic liver disease (MASLD).
Systematic review and meta-analysis of diagnostic test accuracy using the Grading of Recommendations Assessment, Development and Evaluation approach with random-effects models.
PubMed, Embase, Web of Science, Ovid (Medline), Cochrane, China National Knowledge Infrastructure, Wan Fang and OpenGrey were searched for publications from April 1989 to July 2024.
The study included relevant records on the application of pSWE and VCTE in diagnosing MASLD in children (
Two independent reviewers extracted data and assessed the risk of bias. Articles were assessed using Quality Assessment of Diagnostic Accuracy Studies 2 for diagnostic accuracy and potential biases, and bias risks were visually represented using the Risk of Bias Visualisation tool. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic). The analysis of the likelihood ratio graph (Fagan plot) indicates that both pSWE and VCTE provide valuable diagnostic support for MASLD.
The comprehensive literature search yielded four pSWE studies encompassing 968 children and seven VCTE studies encompassing 1934 children. In our meta-analysis, VCTE had a sensitivity of 0.89 (95% CI, 0.79 to 0.94) and a specificity of 0.90 (95% CI, 0.83 to 0.95), which showed superior diagnostic accuracy compared with pSWE (sensitivity, 0.89 (95% CI, 0.81 to 0.94); specificity, 0.85 (95% CI, 0.81 to 0.89)).
While both pSWE and VCTE demonstrated appreciable diagnostic efficacy in paediatric MASLD, VCTE showed similar sensitivity but superior specificity, emerging as the more effective technique particularly in non-obese children. However, further investigation is warranted to fully elucidate the influence of probe selection and racial prevalence on these diagnostic modalities.
CRD42024514246.
Shortening the duration of postoperative radiotherapy (RT) for breast cancer while maintaining efficacy and safety has become a significant trend. The 3-week regimen of 40–42.5 Gy in 15–16 fractions is now a preferred option in clinical practice. Following the publication of the 5-year outcomes from the Fast-Forward trial, interest in 1-week regimens has surged, prompting the initiation of multiple studies. However, trials exploring the 1-week regimen for regional nodal irradiation (RNI), especially involving internal mammary nodes (IMN), remain scarce. Additionally, the optimal fractionation scheme for tumour bed boost in the era of ultra-hypofractionated regimens is still debated. To address these gaps, we initiated the adjuvant regional nodal radiation therapy for one week in breast cancer (ARROW) trial to evaluate the feasibility of a 1-week regimen for RNI of 26 Gy in five fractions, with optional sequential tumour bed boost of 10.4 Gy in two fractions. The findings from our trial are expected to extend the application of ultra-hypofractionated regimens to include sequential tumour bed boosts and RNI, pioneering its use in IMN irradiation.
The ARROW trial is an open-label, single-arm, multicentre phase II trial, encompassing four teaching hospitals in China. Enrolled patients will receive a total of 26 Gy in five fractions to ipsilateral whole breast/chest wall and regional regions, including supraclavicular/infraclavicular nodes, IMN and any portion of the undissected axilla deemed at risk. A sequential tumour bed boost of 10.4 Gy in two fractions is delivered in patients at high risk for recurrence, which is at the discretion of the radiation oncologist. The sample size for the ARROW trial was 197 patients. Both intensity-modulated radiation therapy and proton therapy are permitted. The primary endpoint is acute radiation-induced toxicity, graded according to Radiation Therapy Oncology Group (RTOG) criteria and CTCAE V.3.0. Secondary endpoints include cosmetic outcomes for breast-conserving surgery, late radiation-induced toxicity, local regional recurrence, distant metastasis, invasive tumour-free survival, overall survival and quality-of-life assessment.
The trial has been approved by the Ethical Committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, as well as approvals from the ethical committees of each participating centre have also been obtained. Research findings will be submitted for publication in peer-reviewed journals.
ARROW trial: NCT04509648.