Carcinoma, Adenoid CysticSIBACIRTNCT05733910
Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
A study testing simultaneous integrated boost of carbon ions radiation therapy in people with Carcinoma, Adenoid Cystic and Head and Neck Cancer, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Adenoid Cystic, Head and Neck Cancer
- What is being tested?
- simultaneous integrated boost of carbon ions radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2023to 28 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Karnofsky Performance Status ≥ 70;
- Age ≥ 18 years;
- Written informed consent
- Patients' ability to understand the characteristics and consequences of the clinical trial.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CNAO
Pavia, Pavia, 27100
Cristina Bono, MSc, +39(0)382078613, cristina.bono@cnao.it
About this study
Official title: Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
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.
Read the detailed description
In photon radiotherapy, Simultaneous integrated boost (SIB)-intensity-modulated radiation therapy (IMRT) with slight hypofractionation in the HR-CTV is the current standard of care, being previously largely adopted in clinical practice and within several prospective clinical trials, with similar results in terms of toxicity and oncologic outcome.
Up to now, a simultaneous integrated boost (SIB) approach has not been fully exploited in CIRT so far. The expected benefit of a SIB planning approach in carbon ion treatment is the reduction of toxicity with respect to the sequential (SEQ) approach currently used in CNAO clinical practice, while maintaining the same local control rate. This benefit depends on the potentiality of SIB to better spare normal tissues, further enhancing the intrinsic favourable physical and radiobiological characteristics of the carbon ions.
- Conditions
- Carcinoma, Adenoid Cystic, Head and Neck Cancer
- Being tested
- simultaneous integrated boost of carbon ions radiation therapy
- Keywords
- adenoid cystic carcinoma, hadrontherapy, carbon ion radiation therapy CIRT, head and neck cancer, SIB
- Medical subject headings
- Carcinoma, Adenoid Cystic, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous integrated boost of carbon ions radiation therapyRadiation
Also called CIRT
CIRT Treatment will be delivered in 16 fractions, 4 fractions per week. Treatment plans will be calculated with a Simultaneous Integrated Boost Approach (SIB).
The HR-CTV will receive a total dose of 65.6 GyRBE (4.1 GyRBE/fraction). The LR-CTV will simultaneously receive a total dose of 54.4 GyRBE (3.4 GyRBE/fraction) or 48 GyRBE (3 GyRBE/fraction) at discretion of Radiation Oncologist depending on the prognostic factors (54.4 GyRBE in case of macroscopical perineural invasion or positive margin along the nerve, 48.0 Gy(RBE) in case of elective perineural irradiation or microscopic focal intratumor perineural invasion).
| Study group | Role | What they receive |
|---|---|---|
| carbon ion radiotherapy | Experimental | simultaneous integrated boost with carbon ion radiotherapy Receives: Radiation: simultaneous integrated boost of carbon ions radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and sub acute toxicity as assessed by CTACE 5.0
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
Measured: 90 and 180 days after radiation treatment
Secondary outcomes (2)
local control assessed through head and neck MRI
LC is expected to be the same as in the sequential traditional approach
Measured: from last day of radiation treatment up to 12 months until disease progression or death or last follow up up to 5 years
toxicity evaluation
various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models
Measured: toxicity assessed at 90, 120, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start28 Nov 2023
- Primary completion27 Feb 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Adenoid CysticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will be prospectively enrolled and treated at the sponsor's premises. Only one group of subjects will enter the phase II trial.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Ronchi, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733910
- Sponsor's protocol ID
- CNAO 46 2022C
- Acronym
- SIBACIRT
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
- ClinicalTrials.gov ID
- NCT05733910
- Acronym / sponsor ID
- SIBACIRT / CNAO 46 2022C
- Conditions
- Carcinoma, Adenoid Cystic, Head and Neck Cancer
- Keywords
- adenoid cystic carcinoma, hadrontherapy, carbon ion radiation therapy CIRT, head and neck cancer, SIB
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In photon radiotherapy, Simultaneous integrated boost (SIB)-intensity-modulated radiation therapy (IMRT) with slight hypofractionation in the HR-CTV is the current standard of care, being previously largely adopted in clinical practice and within several prospective clinical trials, with similar results in terms of toxicity and oncologic outcome.
Up to now, a simultaneous integrated boost (SIB) approach has not been fully exploited in CIRT so far. The expected benefit of a SIB planning approach in carbon ion treatment is the reduction of toxicity with respect to the sequential (SEQ) approach currently used in CNAO clinical practice, while maintaining the same local control rate. This benefit depends on the potentiality of SIB to better spare normal tissues, further enhancing the intrinsic favourable physical and radiobiological characteristics of the carbon ions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will be prospectively enrolled and treated at the sponsor's premises. Only one group of subjects will enter the phase II trial.
| Arm | Type | Receives |
|---|---|---|
| carbon ion radiotherapy | Experimental | Radiation: simultaneous integrated boost of carbon ions radiation therapysimultaneous integrated boost with carbon ion radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous integrated boost of carbon ions radiation therapyAlso: CIRTCIRT Treatment will be delivered in 16 fractions, 4 fractions per week. Treatment plans will be calculated with a Simultaneous Integrated Boost Approach (SIB). The HR-CTV will receive a total dose of 65.6 GyRBE (4.1 GyRBE/fraction). The LR-CTV will simultaneously receive a total dose of 54.4 GyRBE (3.4 GyRBE/fraction) or 48 GyRBE (3 GyRBE/fraction) at discretion of Radiation Oncologist depending on the prognostic factors (54.4 GyRBE in case of macroscopical perineural invasion or positive margin along the nerve, 48.0 Gy(RBE) in case of elective perineural irradiation or microscopic focal intratumor perineural invasion). | Radiation | carbon ion radiotherapy |
Primary outcome
acute and sub acute toxicity as assessed by CTACE 5.0
Time frame: 90 and 180 days after radiation treatment
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
2 secondary outcomes
local control assessed through head and neck MRI
Time frame: from last day of radiation treatment up to 12 months until disease progression or death or last follow up up to 5 years
toxicity evaluation
Time frame: toxicity assessed at 90, 120, 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Ronchi, MD principal investigator
CNAO National Center of Oncological Hadrontherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous integrated boost of carbon ions radiation therapy in people with Carcinoma, Adenoid Cystic and Head and Neck Cancer, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Ronchi, MD (+390382078501, sara.ronchi@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute and sub acute toxicity as assessed by CTACE 5.0 (time frame: 90 and 180 days after radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.