This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN. The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area. To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
268
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
conventional radiotherapy, 70Gy in 7 weeks
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
Gustave Roussy Cancer Institute
Villejuif, France
Netherlands Cancer Institute
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Maastro Clinic
Maastricht, Netherlands
locoregional recurrence-free survival
Time frame: 2 years
number of patients with grade 3 toxicity or more
Time frame: 2 years
Quality of Life assessment
Time frame: 2 years
swallowing preservation
Tube feeding dependency at one year
Time frame: 1 year
progression free survival
Time frame: 2 years
overall survival
Time frame: 2 years
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Erasmus Medical Centre
Rotterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
University Hospital Vall d'Hebron
Barcelona, Spain
Karolinska Institute
Stockholm, Sweden
Christie Hospital NHS Trust
Manchester, United Kingdom