16 research outputs found
Kinetic considerations of the strength of oriented solids
Kinetics of mechanical strength of oriented and stressed solids based on statistical absolute reaction rate theor
A note on the paper of V. R. Regel and A. M. Leksovsky “A study of fatigue within the framework of the kinetic concept of fracture”
On the relation between the kinetic parameters involved in molecular chain breakage and macroscopic failure
The physics and micro-mechanics of nano-voids and nano-particles in polymer combinations
In this article the role of voids or particulate inclusions of different sizes on mechanical properties and particularly on toughness in several polymers is discussed. With decreasing void sizes and intervoid distances, the influence of the interphase material around the voids becomes more important and characteristic changes in the nano- and micro-deformation mechanisms appear. These mechanisms are revealed by several techniques of electron microscopy within rubber modified polymers, nanocomposites and nanofibres respectively. Three nanoscopic toughness enhancing mechanisms are described in detail: thin layer yielding, nanovoid-modulated craze-formation, and the core flattening mechanism. The action of these mechanisms constitutes a distinct advantage of nanovoids over microvoids. (c) 2013 Elsevier Ltd. All rights reserved
The HELENA study: Hexvix®-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy—a prospective randomized controlled open-label multicenter non-inferiority study
Purpose
Photodynamic diagnosis and white-light TURB with adjuvant intravesical chemotherapy (ICT) is widely used in treatment of bladder cancer. This non-inferiority trial is designed to demonstrate non-inferiority regarding recurrence-free survival (RFS) of Hexvix® TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT.
Methods
Between 07/2010 and 12/2016, 129 patients with EORTC intermediate risk non-muscle invasive bladder cancer treated with TURB were included in this multicentre phase III study. Patients were randomized and received either white-light TURB with immediate ICT followed by maintenance ICT (n = 62, 20 mg Mitomycin weekly for 6 weeks as induction phase, afterwards 20 mg/month for 6 months) or Hexvix® TURB with immediate ICT only (n = 67, 40 mg Mitomycin). Primary study endpoint was RFS after 12 months. Hexvix® TURB was counted as non-inferior to white light alone if the upper limit of the one-sided 95% confidence interval of hazard ratio was lower than 1.676. Due to the non-inferiority design, the per-protocol population was used as the primary analysis population (n = 113)
Results
Median follow-up was 1.81 years. Hexvix® group showed more events (recurrence or death) than white-light group (19 vs. 10) resulting in a HR of 1.29 (upper limit of one-sided 95%-CI = 2.45; pnon-inferiority = 0.249). The ITT population yielded similar results (HR = 1.67); 3.18], pnon-inferiority = 0.493). There was no significant difference in overall survival between both groups (p = 0.257).
Conclusion
Non-inferiority of Hexvix® TURB relative to white-light TURB with maintenance Mitomycin instillation in intermediate risk urothelial carcinoma of the bladder was not proven. Hence a higher effect of maintenance ICT is to assume compared to a Hexvix®-improved TURB only, confirming its important role in patient treatment