Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma (SIBACIRT)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Carcinoma, Adenoid Cystic
• Intervention / Treatment: Radiation: simultaneous integrated boost of carbon ions radiation therapy

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Ronchi, MD; Phone Number: +390382078501; Email: sara.ronchi@cnao.it
• Study Contact Backup: Name: Cristina Bono, MSc; Phone Number: 0382078613; Email: cristina.bono@cnao.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • CNAO
    • Contact: Cristina Bono, MSc; Phone Number: +39(0)382078613; Email: cristina.bono@cnao.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: carbon ion radiotherapy; simultaneous integrated boost with carbon ion radiotherapy

Radiation: simultaneous integrated boost of carbon ions radiation therapy; 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).; Other Names: CIRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 and 180 days after radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
toxicity evaluation	various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models	toxicity assessed at 90, 120, 180 days
local control assessed through head and neck MRI	LC is expected to be the same as in the sequential traditional approach	from last day of radiation treatment up to 12 months until disease progression or death or last follow up up to 5 years

Collaborators and Investigators

• Sponsor: CNAO National Center of Oncological Hadrontherapy
• Investigators: Principal Investigator: Sara Ronchi, MD, CNAO National Center of Oncological Hadrontherapy

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): February 27, 2026
• Study Completion (Estimated): November 28, 2026

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: head and neck cancer; SIB; adenoid cystic carcinoma; hadrontherapy; carbon ion radiation therapy CIRT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Head and Neck Neoplasms; Carcinoma, Adenoid Cystic
• Other Study ID Numbers: CNAO 46 2022C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No