Carbon ion therapy for head and neck adenoid cystic carcinoma
Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
This study is testing a new way of using carbon ion therapy for patients with hard-to-remove head and neck tumors to see if it can treat the cancer better while causing less harm to healthy tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT05733910 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically-proven, unresectable head and neck adenoid cystic carcinoma or those with residual disease after surgery.
Not a fit: Patients with distant metastases, previous radiotherapy in the head and neck region, or local conditions contraindicating carbon ion radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related toxicity for patients while maintaining effective cancer control.
How similar studies have performed: While the SIB approach has been successful in photon radiotherapy, its application in carbon ion therapy is novel and has not been fully explored in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.