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New treatment option for Carcinoma, Adenoid Cystic
Official title Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
ClinicalTrials.gov ID: NCT05733910
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Local conditions contraindicating CIRT (e.g., active infection or previous history of recurrent infections in or close to the tumor site...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Pavia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.