Table 5.

Early trial termination rule for trials with poor accrual in JCOG

1.5 years after registration starts	2.5 years after registration starts	Whether research fundsa have been obtained	Decision for early termination due to low accrual
Less than 20% of planned accrual pace	–	None	✔ Trial termination in principle
		Obtained	✔ Trial termination or downsizing of sample size not mandated; a grace period of 1 year for accrual is provided ✔ The research group establishes criteria for the number of accruals to be achieved after 1 year ✔ The number of accruals is re-evaluated after 1 year to determine if the criteria are met
–	Less than 50% of planned accrual pace	None	✔ Trial termination in principle ✔ If it is desired to continue the trial, downsizing will be conducted through protocol revision ✔ If downsizing results in a detection power of less than 50% for clinically meaningful differences, the trial will be terminated
		Obtained	✔ Trial termination or downsizing of sample size not mandated; a grace period of 1 year for accrual is provided ✔ The research group establishes criteria for the number of accruals to be achieved after 1 year ✔ The number of accruals is re-evaluated after 1 year to determine if the criteria are met
20% or more of planned accrual pace	50% or more of planned accrual pace	–	✔ Trial continues

^aOther than the National Cancer Center Research and Development Funds