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. 2017 Jan 4;2(1):85–93. doi: 10.1016/j.adro.2016.12.003

Table 1.

Protocol schema

  • Treatment Arms:
    • 1
      IMPT
    • 2
      IMRT
  • Phase 1
    • Minimum of 9 participants per treatment arm; up to 18 participants per treatment arm to allow for DLTs:
      • Dose Level 1 (up to 6 participants per arm)
        • Average Risk PTV: 50.4 GyRBE in 28 fx (1.8 GyRBE/fx)
        • High Risk PTV: 60.2 GyRBE in 28 fx (2.15 GyRBE/fx)
      • Dose Level 2 (up to 6 participants per arm)
        • Average Risk PTV: 50.4 GyRBE in 28 fx (1.8 GyRBE/fx)
        • High Risk PTV: 61.6 GyRBE in 28 fx (2.2 GyRBE/fx)
      • Dose Level 3 (up to 6 participants per arm)
        • Average Risk PTV: 50.4 GyRBE in 28 fx (1.8 GyRBE/fx)
        • High Risk PTV: 63.0 GyRBE in 28 fx (2.25 GyRBE/fx)
    • Within each arm, initial accrual at each dose level is 3 participants.
    • If 1 DLT is observed, 3 additional participants are enrolled at the current dose level to that arm.
    • If no DLTs are observed in the initial cohort or no DLTs are observed among the additional participants, study enrollment will proceed for the next dose level.
    • If ≥2 DLTs are observed in the initial or expanded cohort, the MTD is the prior dose level.
    • If ≥2 DLTs are observed in dose level 1, the dose will lowered to:
      • -
        Average Risk PTV: 50.4 GyRBE in 28 fx (1.8 GyRBE/fx)
      • -
        High Risk PTV: 57.4 GyRBE in 28 fx (2.05 GyRBE/fx)
    • and considered the MTD.
  • Phase 2
    • Twenty-two participants per treatment arm who are treated at the phase 1 MTD
    • (Note: the phase 1 MTD may be different in each arm)

DLT, dose-limiting toxicity; fx, fraction; GyRBE, Gray radiobiological equivalent; MTD, maximum tolerated dose; PTV, planning target volume.