Skip to main content
. 2022 Apr 6;34:99–106. doi: 10.1016/j.ctro.2022.04.003

Table 2.

Characteristics of the 3 + 3 dose-escalation clinical trial design.

Cohort 1 Capecitabine
500 mg/m2, bid
d1-30 during RT
  • •

    DLT 0/3 patients ≫ proceed to cohort 2

    DLT 1/3 patients ≫ expand dose level to 6 patients

    DLT 1/6 patients ≫ proceed to cohort 2

    DLT 2/6 patients ≫ MTD exceeded and trial terminated
Cohort 2 Capecitabine
650 mg/m2, bid
d1-30 during RT
  • •

    DLT 0/3 patients ≫ proceed to cohort 3

    DLT 1/3 patients ≫ expands dose level to 6 patients

    DLT 1/6 patients ≫ proceed to cohort 3

    DLT 2/6 patients ≫ MTD defined as 500 mg/m2, bid
Cohort 3 Capecitabine
825 mg/m2, bid
d1-30 during RT
  • •

    DLT 0/3 patients ≫ maximum dose reached (825 mg/m2, bid)

    DLT 1/3 patients ≫ expand dose level to 6 patients

    DLT 1/6 patients ≫ maximum dose reached (825 mg/m2, bid)

    DLT 2/6 patients ≫ MTD defined as 650 mg/m2, bid