Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma

Recruiting now · Not applicable

Conditions studied: Carcinoma, Adenoid Cystic, Head and Neck Cancer

In brief

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.

Key facts

Study ID: NCT05733910
Run by: CNAO National Center of Oncological Hadrontherapy
People needed: 42
Starts: 2023-11-28
Expected to finish: 2026-11-28
Last updated by the study team: 2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

CNAO — Pavia, Pavia, Italy (enrolling)

Full record on ClinicalTrials.gov

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