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Not Yet Recruiting NCT05733910

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

Conditions: Carcinoma, Adenoid Cystic, Head and Neck Cancer

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 42
Sponsor: CNAO National Center of Oncological Hadrontherapy

Location: Italy

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 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 surgerycN0/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 consentPatients' 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 CIRTNodal involvement > cN1/pN1 or cN1/pN1 outside ipsilateral levels I and IITumor surrounding carotid artery > 180° or infiltrating the vesselsitanium 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 planningPresence of any comorbidity deemed to impact on treatment toxicity;Psychic or other disorders that may prevent informed consentActive autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)Contraindication to MRIPregnancy or breastfeeding in progress

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05733910). StuddyBuddy aggregates publicly available trial information.