Table 1 Summary of dose escalation studies.
Dose level | Number of fractions | Dose per fraction (Gy) | Total Dose (Gy) | BED α/β = 3 | BED α/β = 10 | Elapsed days | Days of treatment | Field size | Strain | Incidence of severe toxicity/death | Death post SART (weeks) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Male | Female | |||||||||||
DL1 | 1 | 15 | 15 | 90 | 38 | N/A | 1 | 2 cm | C57Bl/6 | 0 of 3 | ||
2 | 10.2 | 20.4 | 90 | 41 | 8 | 1,8 | 2 cm | C57Bl/6 | 0 of 3 | |||
3 | 8.1 | 24.3 | 90 | 44 | 9 | 1,5,9 | 2 cm | C57Bl/6 | 0 of 3 | |||
5 | 6 | 30 | 90 | 48 | 9 | 1,3,5,7,9 | 2 cm | C57Bl/6 | 0 of 3 | 0 of 3 | ||
DL2 | 1 | 18.3 | 18.3 | 130 | 52 | N/A | 1 | 2 cm | C57Bl/6 | 0 of 3 | ||
2 | 12.6 | 25.2 | 131 | 57 | 8 | 1,8 | 2 cm | C57Bl/6 | 0 of 3 | |||
3 | 10 | 30 | 130 | 60 | 9 | 1,5,9 | 2 cm | C57Bl/6 | 0 of 3 | |||
5 | 7.5 | 37.5 | 131 | 66 | 9 | 1,3,5,7,9 | 2 cm | C57Bl/6 | 0 of 3 | 1 of 3 | 16 | |
5 | 7.5 | 37.5 | 131 | 66 | 5 | 1,2,3,4,5 | 2 cm | C57Bl/6 | 1 of 5 | 3 of 5 | 12–16 | |
5 | 7.5 | 37.5 | 131 | 66 | 9 | 1,3,5,7,9 | 2 cm | CD-1 | 0 of 6 | |||
5 | 7.5 | 37.5 | 131 | 66 | 9 | 1,3,5,7,9 | 1 cm (pelvis) | CD-1 | 0 of 6 | |||
5 | 7.5 | 37.5 | 131 | 66 | 9 | 1,3,5,7,9 | 1 cm (low abd) | C57Bl/6 | 1 of 4 | 14 | ||
DL3 | 1 | 21.8 | 21.8 | 180 | 69 | N/A | 1 | 2 cm | C57Bl/6 | 0 of 2 | ||
2 | 15 | 30 | 180 | 75 | 8 | 1,8 | 2 cm | C57Bl/6 | 0 of 3 | |||
3 | 12 | 36 | 180 | 79 | 9 | 1,5,9 | 2 cm | C57Bl/6 | 0 of 3 | |||
5 | 9 | 45 | 180 | 86 | 9 | 1,3,5,7,9 | 2 cm | C57Bl/6 | 1 of 3 | 2 of 3 | 7–12 | |
5 | 9 | 45 | 180 | 86 | 9 | 1,3,5,7,9 | 1 cm (pelvis) | C57Bl/6 | 0 of 4 | |||
5 | 9 | 45 | 180 | 86 | 9 | 1,3,5,7,9 | 1 cm (low abd) | C57Bl/6 | 2 of 4 | 9–10 | ||
DL4 | 2 | 18 | 36 | 252 | 101 | 8 | 1,8 | 2 cm | C57Bl/6 | 0 of 3 | ||
3 | 14.4 | 43.2 | 251 | 105 | 9 | 1,5,9 | 2 cm | C57Bl/6 | 3 of 3 | 14–17 | ||
5 | 10.9 | 54.5 | 253 | 114 | 9 | 1,3,5,7,9 | 2 cm | C57Bl/6 | 3 of 3 | 5 | ||