1118-1119 / 2063
Study design
•
Phase III superiority study
•
Primary endpoint:
loco-regional control rate
•
Secondary endpoints: local control, regional control, time to distant
metastases, overall survival, disease-free survival, disease-specific
survival, acute and late morbidity
•
Stratification
for:
•
Institution
•
Localization: hypopharynx
vs
oropharynx
vs
larynx
•
T-stage: T1-2
vs
T3-4
•
N-stage: N0-1
vs
N2-3
•
WHO - PS: 0-1
vs
2
•
Hypoxic gene-profile: positive
vs
negative
vs
undetermined
•
Size:
640 patients
(320 in each treatment arm)
(the recruitment will continue until
200 patients are available in the hypoxic signature
positive
subgroup)