Purpose. To investigate the role of induction chemotherapy (IC) followed by definitive chemoradiotherapy (CRT) in anal canal cancer population with bulky disease at diagnosis.
Methods and materials. To assess patient acceptability and treatment feasibility of IC in patients with bulky anal canal malignant lesion.
Results. Theoretical IC advantages may include tumor down-sizing and early micrometastasis eradication, without affect compliance on subsequent standard CRT, due to improvement of oxygenation and higher intramural concentration of cytotoxic drugs.
Conclusion. Study design should be proven feasible with a satisfactory patient acceptance rate and an optimized workflow. This study is the first trial to investigate use of IC in bulky anal canal cancer population.
Despite pilot studies are very useful, not many are reported in literature [6]. Our aim is to obtain the required preliminary data for the calculation of a sample size for the primary outcome. Strength of this study is the unambiguous definitions of time-to-event endpoints, according to Glynne-Jones et al. recommendations [7]. It improves data reporting and assures data uniformity of endpoints explored. The aim is to guarantee endpoints reproducibility and facilitate accurate comparisons between studies in the near future. From a theoretical point of view, IC represents a safe, reasonable and easily accessible choice in bulky anal canal lesions. With this in mind, if proved safe, effective and reliable, IC has the potential to become a standard approach in bulky disease in referral centers. We hope to provide necessary information for calculating sample size and assessing all aspects of the main study, minimizing the dissipation of research resources.
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