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

Primary Purpose

Carcinoma, Adenoid Cystic, Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
simultaneous integrated boost of carbon ions radiation therapy
Sponsored by
CNAO National Center of Oncological Hadrontherapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carcinoma, Adenoid Cystic focused on measuring adenoid cystic carcinoma, hadrontherapy, carbon ion radiation therapy CIRT, head and neck cancer, SIB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CNAO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carbon ion radiotherapy

Arm Description

simultaneous integrated boost with carbon ion radiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

local control assessed through head and neck MRI
LC is expected to be the same as in the sequential traditional approach
toxicity evaluation
various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models

Full Information

First Posted
January 24, 2023
Last Updated
May 24, 2023
Sponsor
CNAO National Center of Oncological Hadrontherapy
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1. Study Identification

Unique Protocol Identification Number
NCT05733910
Brief Title
Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Acronym
SIBACIRT
Official Title
Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
February 27, 2026 (Anticipated)
Study Completion Date
November 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CNAO National Center of Oncological Hadrontherapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Adenoid Cystic, Head and Neck Cancer
Keywords
adenoid cystic carcinoma, hadrontherapy, carbon ion radiation therapy CIRT, head and neck cancer, SIB

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
carbon ion radiotherapy
Arm Type
Experimental
Arm Description
simultaneous integrated boost with carbon ion radiotherapy
Intervention Type
Radiation
Intervention Name(s)
simultaneous integrated boost of carbon ions radiation therapy
Other Intervention Name(s)
CIRT
Intervention 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).
Primary Outcome Measure Information:
Title
acute and sub acute toxicity as assessed by CTACE 5.0
Description
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
Time Frame
90 and 180 days after radiation treatment
Secondary Outcome Measure Information:
Title
local control assessed through head and neck MRI
Description
LC is expected to be the same as in the sequential traditional approach
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
Title
toxicity evaluation
Description
various toxicity endpoints will be aggregated and analysed to build predictive factors to build multivariate predictive models
Time Frame
toxicity assessed at 90, 120, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Ronchi, MD
Phone
+390382078501
Email
sara.ronchi@cnao.it
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Bono, MSc
Phone
0382078613
Email
cristina.bono@cnao.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Ronchi, MD
Organizational Affiliation
CNAO National Center of Oncological Hadrontherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CNAO
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

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

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