💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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)
* Absence of distant metastases or oligometastatic status (patients with ≤ 3 metastatic lung or bone lesions, excluding other sites;
* No previous radiotherapy in head and neck region;
* Karnofsky Performance Status ≥ 70;
* Age ≥ 18 years;
* Written informed consent
* Patients' ability to understand the characteristics and consequences of the clinical trial.
Exclusion Criteria:
* 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
* Tumor surrounding carotid artery \> 180° or infiltrating the vessels
* itanium surgical implants or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and may determine uncertainties in CIRT dose distribution during treatment planning
* Presence of any comorbidity deemed to impact on treatment toxicity;
* Psychic or other disorders that may prevent informed consent
* Active autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)
* Contraindication to MRI
* Pregnancy or breastfeeding in progress
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