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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCNAO National Center of Oncological Hadrontherapy

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • simultaneous integrated boost of carbon ions radiation therapy

Treatment groups

42 Participants
are divided into 1 treatment group