Actively Recruiting
Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2025-02-13
42
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-proven primary head and neck adenoid cystic carcinoma
- Unresectable stage or residual macroscopic disease after surgery or multiple microscopic margins after surgery
- Patients with resectable tumor but refusing surgery
- cN0/pN0 or cN1/pN1 patients limited to ipsilateral neck levels I and II
- Absence of distant metastases or oligometastatic status (3 or fewer metastatic lung or bone lesions only)
- No previous radiotherapy in the head and neck region
- Karnofsky Performance Status of 70 or higher
- Age 18 years or older
- Written informed consent provided
- Ability to understand the trial characteristics and consequences
You will not qualify if you...
- Local conditions preventing carbon ion radiotherapy (e.g., active or recurrent infections near tumor site, intratumoral necrosis near vessels, pre-existing fistula, extensive mucosal tumor involvement, previous flap reconstruction surgery)
- Tumor located in nasopharynx, pharynx, or tongue base where exclusive carbon ion radiotherapy poses high toxicity risk
- Tumor involving 50% or more of the palate with risk of serious anatomical damage
- Nodal involvement beyond cN1/pN1 or outside ipsilateral levels I and II
- Tumor surrounding carotid artery more than 180 degrees or infiltrating vessels
- Titanium surgical implants, metal prostheses, or other conditions affecting imaging and treatment planning accuracy
- Any comorbidity impacting treatment toxicity
- Psychiatric or other disorders preventing informed consent
- Active autoimmune diseases such as lupus, systemic sclerosis, or rheumatoid arthritis
- Contraindication to MRI
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CNAO
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
S
Sara Ronchi, MD
CONTACT
C
Cristina Bono, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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