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

Trial Title: Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma

NCT ID: NCT05733910

Condition: Carcinoma, Adenoid Cystic
Head and Neck Cancer

Conditions: Official terms:
Carcinoma
Head and Neck Neoplasms
Carcinoma, Adenoid Cystic

Conditions: Keywords:
adenoid cystic carcinoma
hadrontherapy
carbon ion radiation therapy CIRT
head and neck cancer
SIB

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention 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.

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: simultaneous integrated boost of carbon ions radiation therapy
Description: 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).
Arm group label: carbon ion radiotherapy

Other name: CIRT

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 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CNAO

Address:
City: Pavia
Zip: 27100
Country: Italy

Status: Recruiting

Contact:
Last name: Cristina Bono, MSc

Phone: +39(0)382078613
Email: cristina.bono@cnao.it

Start date: November 28, 2023

Completion date: November 28, 2026

Lead sponsor:
Agency: CNAO National Center of Oncological Hadrontherapy
Agency class: Other

Source: CNAO National Center of Oncological Hadrontherapy

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05733910