1748-1749 / 2605
Eligibility
1)
Stage III-IV
oropharyngeal
cancer
2)
Squamous cell
carcinoma
3)
ECOG<2
4)
Target volume
delineation
R
A
N
D
O
M
I
Z
A
T
I
O
N
IMPT
(70 Gy(RBE))
Chemotherapy (locally
advanced disease)
IMRT
(70 Gy)
Chemotherapy (locally
advanced disease)
Treatment
33 days
PROs
Recovery
10 wks
Restaging
PROs Q3
mo
PROs
Q3 mo
Surgery
No Surgery
Follow-up
Follow-up
H-N Phase II/III Randomized Trial (MDACC)
Oropharyngeal Cancer - IMPT vs IMRT
Frank – PI
Trial Activated – Sept 2013
Primary endpoint: CTC-AE G3+ toxicity at 90 days – 2 years
Courtesy Steve Frank
Tremendous effort to conduct this trial.
If Phase II trials would have been done first – maybe they would
have shown that 78 Gy(RBE) of protons can safely be delivered
AND result in superior local control.
Then this trial could be 78 Gy(RBE) versus 70 Gy photons and
yield much more information than just toxicity reduction