Table 3.

Single-Arm, Two-Stage, Phase II Trial Design for Patients With Measurable, Unresectable Osteosarcoma With an Event-Free Survival End Point According to the Historical Benchmark From This Analysis

Stage	Cumulative No. Enrolled	Cumulative No. With Disease Control ≥ 4 Months	Decision
1	19	≤ 3	Terminate enrollment with the conclusion that the agent is not efficacious
2	36	≥ 4	Continue enrollment
		≤ 10	Consider the agent ineffective
		≥ 11	Consider the agent of sufficient efficacy for additional study