Finding studies
Finding studies
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Lead
Gruppo Oncologico Italia Meridionale
The study aims primarily to verify the null hypothesis that between the two schemes under consideration there is no minimal interesting difference (MID) (i.e. a difference of clinical interest) after initial 3 months of maintenance.EuroQ5D (EQ5D) questionnaire total score and EQ5D visual analog scale (VAS)are validated and very simple to be administered.The statistical hypothesis tests described above are performed with t-test for unpaired data (or equivalent non-parametric, pending verification of normality of distribution by Shapiro-Wilk test), with alpha error = 0.05 (2-sided). It is assumed that: 1. about 20% of randomized patients experienced a progression of disease before the time of evaluation of the primary endpoint, and that 2. this eventuality was not significantly different between the two treatments. The total sample to be enrolled for this study will then be increased to 118 patients \[(49 +49) +20%)\]
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
