The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy \[RBE\] in 2-3 Gy \[RBE\] per fractions for 8-15 total fractions. PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy \[RBE\]. Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.
CNAO
Pavia, Italy
Local response
RECIST criteria
Time frame: 90 days
Acute toxicity
According to CTCAE v4.0
Time frame: 90 days
Local control
RECIST criteria on MRI evaluation
Time frame: 5 years
Disease free survival
RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
Time frame: 5 years
Overall survival
On MRI and total body CT evaluation - months from RT treatment to death
Time frame: 5 years
Late toxicity
According to CTCAE v4.0 registered during follow up visits
Time frame: 5 years
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