Setup error analysis in helical tomotherapy based image-guided radiation therapy treatments

The adequacy of setup margins for various sites in patients treated with helical tomotherapy was investigated. A total of 102 patients were investigated. The breakdown of the patients were as follows: Twenty-five patients each in brain, head and neck (H and N), and pelvis, while 12 patients in lung and 15 in craniospinal irradiation (CSI). Patients were immobilized on the institutional protocol. Altogether 2686 megavoltage computed tomography images were analyzed with 672, 747, 622, 333, and 312 fractions, respectively, from brain, H and N, pelvis, lung, and CSI. Overall systematic and random errors were calculated in three translational and three rotational directions. Setup margins were evaluated using van Herk formula. The calculated margins were compared with the margins in the clinical use for various directions and sites. We found that the clinical isotropic margin of 3 mm was adequate for brain patients. However, in the longitudinal direction it was found to be out of margin by 0.7 mm. In H and N, the calculated margins were well within the isotropic margin of 5 mm which is in clinical use. In pelvis, the calculated margin was within the limits, 8.3 mm versus 10 mm only in longitudinal direction, however, in vertical and lateral directions the calculated margins were out of clinical margins 11 mm versus 10 mm, and 8.7 mm versus 7.0, mm respectively. In lung, all the calculated margins were well within the margins used clinically. In CSI, the variation was found in the middle spine in the longitudinal direction. The clinical margins used in our hospital are adequate enough for sites H and N, lung, and brain, however, for CSI and pelvis the margins were found to be out of clinical margins

Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials:HNCIG international consensus recommendations.

Transparent and precise endpoint definitions are a critical aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions in oncological clinical trials. Here, the Head Neck Cancer International Group reports endpoint definitions from trial published between 2008-2021 in phase 3 trials or trials considered potentially practice-changing in the recurrent metastatic setting for patients with mucosal head and neck squamous cell carcinoma. We identify significant and global heterogeneity in endpoint definitions which potentially undermines the interpretation of results and development of future studies. We demonstrate how fundamental components of even seemingly incontrovertible endpoints such as overall survival varies widely, highlighting an urgent need for increased rigor in reporting and harmonisation of endpoint reporting

Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.</p