NCT05733910 Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
| NCT ID | NCT05733910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CNAO National Center of Oncological Hadrontherapy |
| Condition | Carcinoma, Adenoid Cystic |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2026-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2023-11-28 with a primary completion date of 2026-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sara Ronchi, MD
PRINCIPAL INVESTIGATOR
CNAO National Center of Oncological Hadrontherapy
Frequently Asked Questions
Who can join the NCT05733910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Adenoid Cystic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05733910 currently recruiting?
Yes, NCT05733910 is actively recruiting participants. Contact the research team at sara.ronchi@cnao.it for enrollment information.
Where is the NCT05733910 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT05733910 clinical trial?
NCT05733910 is sponsored by CNAO National Center of Oncological Hadrontherapy. The principal investigator is Sara Ronchi, MD at CNAO National Center of Oncological Hadrontherapy. The trial plans to enroll 42 participants.