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Table 3 Statistical sample size calculation

From: PRIMMO study protocol: a phase II study combining PD-1 blockade, radiation and immunomodulation to tackle cervical and uterine cancer

  Null hypothesis (H0) Total number of patients required Number of responses needed for H0 rejection Alternative hypothesis Type I error power
Cervical cancer π > 10% 18 5 π =35% 5% 80%
Endometrial carcinoma π > 10% 25 6 π =30% 5% 79.3%
Uterine sarcoma No sample size calculation is performed due to the rarity of the disease, but these patients will be allowed on the study