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

NCT05733910 | Recruiting

• 1 other identifier: CNAO 46 2022C
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Adenoid Cystic; Head and Neck Cancer

Keywords

adenoid cystic carcinoma; hadrontherapy; carbon ion radiation therapy CIRT; head and neck cancer; SIB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• local control assessed through head and neck MRI

  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

  toxicity assessed at 90, 120, 180 days

Study Arms (1)

carbon ion radiotherapy

EXPERIMENTAL

simultaneous integrated boost with carbon ion radiotherapy

Radiation: simultaneous integrated boost of carbon ions radiation therapy

Interventions

simultaneous integrated boost of carbon ions radiation therapy RADIATION

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).

Also known as: CIRT

carbon ion radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Sara Ronchi, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ronchi, MD

CONTACT

+390382078501; sara.ronchi@cnao.it

Cristina Bono, MSc

CONTACT

0382078613; cristina.bono@cnao.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be prospectively enrolled and treated at the sponsor's premises. Only one group of subjects will enter the phase II trial.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 17, 2023
• Study Start: November 28, 2023
• Primary Completion: February 27, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IT (1)