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Table 5 Optimal two-stage parameters for designs that minimize either the ETSL (top line) or the EDA (bottom line) for testing H0: S(1) ≤ .35. Power is specified for S(1) = .5.#

From: Design of Phase II cancer trials evaluating survival probabilities

α 1 - β DA/x* t 1 C 1 C 2 I 1/Imax EDA MDA ETSL MTSL
.1 .9 1.50 1.01 .488 1.154 .49 1.05 1.15 .76 1.09
    .81 -.489 1.257 .32 .96 1.03 .85 1.02
   1.75 .93 .457 1.159 .48 1.00 1.15 .76 1.10
    .76 -.291 1.245 .34 .94 1.05 .82 1.03
   2 .87 .434 1.163 .47 .96 1.15 .75 1.10
    .72 -.179 1.237 .36 .92 1.06 .80 1.04
   3 .74 .375 1.172 .46 .88 1.15 .75 1.11
    .63 .004 1.220 .38 .86 1.09 .77 1.07
   4 .67 .346 1.176 .45 .84 1.15 .75 1.12
    .59 .073 1.212 .39 .83 1.10 .76 1.08
.05 .95 1.50 .99 .680 1.536 .46 1.03 1.17 .72 1.10
    .81 -.274 1.622 .32 .95 1.04 .81 1.02
   1.75 .91 .648 1.541 .46 .98 1.16 .72 1.10
    .75 -.084 1.612 .34 .92 1.06 .78 1.04
   2 .85 .624 1.545 .45 .94 1.16 .71 1.11
    .72 .024 1.605 .35 .89 1.07 .76 1.05
   3 .72 .563 1.553 .44 .85 1.16 .71 1.12
    .63 .202 1.591 .38 .83 1.10 .72 1.08
   4 .66 .531 1.557 .44 .80 1.15 .70 1.12
    .59 .266 1.586 .39 .79 1.11 .71 1.09
  1. # DA is the fixed sample duration of accrual; x* is the survival time of interest; t 1 is the time of the first interim review; C 1 and C 2 are the cutpoints for acceptance at the first stage and rejection at the second stage; I1 and Imax are the information available at the interim and final reviews; EDA and MDA are the expected and maximum duration of accrual relative to the single stage values; and ETSL and MTSL are the expected and maximum total study length relative to the single stage values. Expected values are calculated under the null hypothesis.