ESTRO PT 2018

Study Design

• A Randomized, Parallel, Non-inferiority Phase III Study will be used to assess the 3-year PFS rates between patients receiving IMPT and IMRT. • A 9 percentage point boundary was selected as the non-inferiority margin for the IMPT group • PFS rate for Protons is no more than δ lower than the PFS rate for IMRT (noting that a higher PFS rate is better) Hypothesis of Interest

H H

: P : P

– P – P

≥ 0.09

0

IMRT

IMPT

= 0 (implying < 0.09)

a

IMRT

IMPT