The investigators aim at investigating in a prospective clinical trial whether using a Simoultaneous Integrated Boost of carbon ions treatment planning approach, improving the tumor dose conformation while lowering the unintended dose to the low-risk volume, can significantly reduce the probability of toxicity without affecting Local Control.
Histologically-proven primary head and neck ACC;
Unresectable stage or residual macroscopic disease after surgery or multiple microscopic margins after surgery;
Patient with resectable tumor but refusing surgery
cN0/pN0 - cN1/pN1 patients (only ipsilateral neck levels I and II)
Local conditions contraindicating CIRT (e.g., active infection or previous history of recurrent infections in or close to the tumor site; intratumoral necrosis in strict proximity of vessels; pre-existing skin, bone or soft tissue fistula; extended mucosal involvement by the tumor; previous surgery with flap reconstruction);
Tumour site in nasopharynx, pharynx and tongue base (where an exclusive CIRT treatment could be at high risk of toxicity);
Tumor disease involving ≥ 50% of the palate with consequent high risks of serious anatomical damage in case of significant and rapid disease response to CIRT
Nodal involvement > cN1/pN1 or cN1/pN1 outside ipsilateral levels I and II
Single group
simultaneous integrated boost of carbon ions radiation therapy
RadiationCIRT Treatment will be delivered in 16 fractions, 4 fractions per week. Treatment plans will be calculated with a Simultaneous Integrated Boost Approach (SIB). The HR-CTV will receive a total dose of 65.6 GyRBE (4.1 GyRBE/fraction). The LR-CTV will simultaneously receive a total dose of 54.4 GyRBE (3.4 GyRBE/fraction) or 48 GyRBE (3 GyRBE/fraction) at discretion of Radiation Oncologist depending on the prognostic factors (54.4 GyRBE in case of macroscopical perineural invasion or positive margin along the nerve, 48.0 Gy(RBE) in case of elective perineural irradiation or microscopic focal intratumor perineural invasion).
acute and sub acute toxicity as assessed by CTACE 5.0
Acute and subacute toxicity will be assessed with clinical evaluation within 180 days after the end of treatment and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
local control assessed through head and neck MRI
LC is expected to be the same as in the sequential traditional approach
toxicity evaluation
various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models
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