NCT05733910Recruiting
Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 24 Jan 2023
- Start date
- 28 Nov 2023
- Primary completion date
- 27 Feb 2026
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Diseases
- Head and neck cancer
- NCT number
- NCT05733910
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 28 Nov 2023 to the primary completion date, 27 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- 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
- 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
- Psychic or other disorders that may prevent informed consent
- Active autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)
Other
- Tumour site in nasopharynx, pharynx and tongue base (where an exclusive CIRT treatment could be at high risk of toxicity);
- Nodal involvement \> cN1/pN1 or cN1/pN1 outside ipsilateral levels I and II
- Tumor surrounding carotid artery \> 180° or infiltrating the vessels
- Presence of any comorbidity deemed to impact on treatment toxicity;
- Contraindication to MRI
- Pregnancy or breastfeeding in progress
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CNAO Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.