1356 / 2351
5/30/16
11
PARADIGM Study Design
Stage III/IV SCC
Oral cavity, Oropharynx,
Hypopharynx, Larynx
Expected N=330
R
A
N
D
O
M
I
Z
E
Docetaxel
Cisplatin
5-FU
every 3 weeks x3
Docetaxel
(wkly for 4 wks)
Accelerated Boost
RT
(d1-5)
6 wks
Carboplatin
(every wk)
Daily RT
(d1-5)
7 wks
Cisplatin
(wks 1,4)
Accelerated Boost RT
(d1-5)
6 wks
NR
CR
A
A1
A2
B
Courtesy of Haddad et al., ASCO 2012
CH-RT >< induction chemo + CH-RT
EHNS-ESTRO H&N course
Florence, June 2016
0.0
0.2
0.4
0.6
0.8
1.0
Survival (Months)
0
12
24
36
48
60
Log Rank Test p=0.77
S
u
r
v
i
v
a
l
P
r
o
b
a
b
i
l
i
t
y
Treatment
Upfront Cisplatin CRT
TPF->CRT
Courtesy of Haddad et al., ASCO 2012
PARADIGM
Primary Endpoint: Overall Survival
CRT
TPF + CRT
CH-RT >< induction chemo + CH-RT
EHNS-ESTRO H&N course
Florence, June 2016