Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials

Table 3 TTP and RR Thresholds Generated with Censoring set at 0.1

Response		Time to Progression		Study Size		Stage 1 Drug Rejection		Stage 2 Drug Acceptance		Power	Alpha Error	EN_nul /PES_nul	EN_alt /PES_alt
r _alt	r _nul	ttp _alt	ttp _nul	n ₁	n ₂	r ₁	epd	r ₁+r ₂	ttp
0.05	0.2	3	6	15	15	≤ -1	≥ 16	≥ 5	≥ 5.5	0.812	0.034	30/0	30/0
0.05	0.2	3	7	15	15	≤ 0	≥ 5	≥ 5	≥ 6.25	0.822	0.021	26.8/0.21	29.8/0.01
0.05	0.2	4	7	15	15	≤ 0	≥ 4	≥ 5	≥ 6.25	0.811	0.084	26.8/0.21	29.5/0.03
0.05	0.2	4	8	15	15	≤ 0	≥ 10	≥ 5	≥ 7.25	0.818	0.038	29.998/ 0.0001	29.998/ 0.0001
0.05	0.2	5	8	15	15	≤ 0	≥ 9	≥ 5	≥ 7.25	0.821	0.151	29.996/ 0.0003	29.995/ 0.0004
0.1	0.3	3	7	15	15	≤ 2	≥ 5	≥ 7	≥ 6	0.864	0.033	24.4/0.37	29.5/0.03
0.1	0.3	4	7	15	15	≤ 2	≥ 4	≥ 7	≥ 6	0.837	0.106	24.4/0.38	28.9/0.08
0.1	0.3	4	8	15	15	≤ 1	≥ 4	≥ 7	≥ 7	0.859	0.054	26.2/0.25	29.6/0.03

ISSN: 1471-2288