Carbon ion therapy for head and neck adenoid cystic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of a Simultaneous Integrated Boost (SIB) approach in carbon ion radiotherapy for patients with adenoid cystic carcinoma of the head and neck. The goal is to improve tumor dose conformation while minimizing the dose to surrounding healthy tissues, thereby reducing toxicity without compromising local control of the cancer. The trial will include patients with unresectable tumors or those who refuse surgery, and it aims to evaluate the effectiveness of this innovative treatment planning method compared to traditional sequential approaches.

Why it matters

Who can join: the full rules

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

Where it's running

• Cnao
  Pavia, Pavia, Italy Recruiting

Study contacts

• Principal investigator: Sara Ronchi, MD — CNAO National Center of Oncological Hadrontherapy
• Study coordinator: Sara Ronchi, MD
• Email: sara.ronchi@cnao.it
• Phone: +390382078501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.