Clinical trial · Interventional
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
NCT05733910CI-TRIAL-00085947SIBACIRTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Adenoid Cystic | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simultaneous integrated boost of carbon ions radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carbon ion radiotherapy
- description
- simultaneous integrated boost with carbon ion radiotherapy
- interventionNames
- Radiation: simultaneous integrated boost of carbon ions radiation therapy
Primary outcomes (1)
- measure
- acute and sub acute toxicity as assessed by CTACE 5.0
- timeFrame
- 90 and 180 days after radiation treatment
- description
- Acute and subacute toxicity will be assessed with clinical evaluation within 180 days after the end of treatment and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Secondary outcomes (2)
- measure
- local control assessed through head and neck MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.