1026 / 1578
/
/
Experiences from a phase I trial
Fractionation
5 x 9Gy
5 x 9.5Gy
5 x 10Gy
Patients
15
15
15
Median FU
30 mo
18 mo
12 mo
% with G3 Tox
0%
0%
0%
Ø
Endpoint: Freedom from toxicity @ 90 days
Ø
„Dose limiting toxicity not reached“
Boike 2011
Phase I dose escalation study
Matthias Guckenberger - ESTRO SBRT Course 2017
7
07.09.17
/
/
Experiences from a phase I trial
Kim IJROBP 2014
•
Median Follow-up: still only 25 months
•
5 x 10Gy arm:
Ø
6 / 61 patients with G3+ rectal toxicity
Ø
5 / 61 patients required colostomy
Matthias Guckenberger - ESTRO SBRT Course 2017
8
Ø
Dose constraints for rectum ?
Ø
„Just too much“ ?
07.09.17