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

Launched by CNAO NATIONAL CENTER OF ONCOLOGICAL HADRONTHERAPY · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat a type of head and neck cancer called adenoid cystic carcinoma using a method called carbon ion radiotherapy. The goal is to see if this treatment can deliver a higher dose of radiation directly to the tumor while reducing the radiation exposure to the surrounding healthy tissues. This approach may help minimize side effects and improve the treatment's effectiveness without affecting the control of the cancer.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of adenoid cystic carcinoma that cannot be fully removed by surgery. This includes patients who have had surgery but still have remaining cancer or those who choose not to have surgery. Participants should not have had previous radiation treatment in the head and neck area and should be able to understand the trial's details. Those who join can expect close monitoring during the treatment process, but there are specific conditions that may prevent someone from participating, such as certain health issues or locations of the tumor that pose high risks.

Gender

ALL

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