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

Sponsor
CNAO National Center of Oncological Hadrontherapy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05733910
Collaborator
(none)
42
1
1
45
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: simultaneous integrated boost of carbon ions radiation therapy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
42 participants
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.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)
Primary Purpose:
Other
Official Title:
Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Feb 27, 2026
Anticipated Study Completion Date :
Nov 28, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. change of acute and sub acute toxicity (according to CTCAE) [90 and 180 days after ratiation 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

    Secondary Outcome Measures

    1. local control [from last day of radiation treatment up to 12 months until disease progression or death]

      LC should be the same as in the sequential traditional approach

    2. toxicity evaluation [toxicity assessed at 90, 120, 180 days]

      various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CNAO Pavia Italy 27100

    Sponsors and Collaborators

    • CNAO National Center of Oncological Hadrontherapy

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CNAO National Center of Oncological Hadrontherapy
    ClinicalTrials.gov Identifier:
    NCT05733910
    Other Study ID Numbers:
    • CNAO 46 2022C
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CNAO National Center of Oncological Hadrontherapy
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2023