simultaneous integrated boost of carbon ions radiation therapy
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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
acute and sub acute toxicity as assessed by CTACE 5.0 — 90 and 180 days after radiation 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
Trial sites (1)
Facility
City
Region
Status
CNAO
Pavia
Pavia
Recruiting
More CNAO National Center of Oncological Hadrontherapy trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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