Planned sample size
For this single-arm pilot study, the planned sample size is 15 patients. With a sample size of 15 patients, the maximum width of a Clopper–Pearson exact 95% CI is 0.52. Since the interval may not be symmetric, this corresponds to approximately ± 0.26, if the response rate is as high as seven of 15. If the response rate is lower than this, the width of the CI will be less. With this sample size, we will be able to determine whether the response rate in this treatment is sufficient to warrant future examination. Based on the preliminary data presented in 