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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