Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma (SIBACIRT)
Carcinoma, Adenoid Cystic, Head and Neck Cancer
About this trial
This is an interventional other trial for Carcinoma, Adenoid Cystic focused on measuring adenoid cystic carcinoma, hadrontherapy, carbon ion radiation therapy CIRT, head and neck cancer, SIB
Eligibility Criteria
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
Sites / Locations
- CNAO
Arms of the Study
Arm 1
Experimental
carbon ion radiotherapy
simultaneous integrated boost with carbon ion radiotherapy