Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059208) titled 'A Prospective Study on Selective Field Expansion During Carbon-ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Gunma University

Condition: Condition - Head and Neck Adenoid Cystic Carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study was to examine the impact of differences in Carbon-ion Radiotherapy treatment planning based on the presence or absence of perineural tumor spread (PNTS) in patients with head and neck adenoid cystic carcinoma on local control and treatment-related adverse events. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The radiation field is defined not only based on the gross tumor volume (GTV) confirmed radiologically on CT and MRI scans taken during treatment planning, but also considering high-risk anatomical structures adjacent to the tumor site that adenoid cystic carcinoma is known to readily invade (e.g., nerve, muscle, and bone tissue spaces). The GTV is targeted for the full planned treatment dose (64 or 57.6 Gy RBE; Relative Biological Effectiveness), and a margin is added to establish the clinical target volume (CTV).CTV is defined in two stages (CTV1: first half, CTV2: second half). For the PNTS (-) group, the conventional treatment plan of 36 GyRBE in the first half is applied, with the GTV + 5 mm margin defined as CTV1. Conversely, for the PNTS (+) group, CTV1 is defined by adding an additional +5 mm margin toward the central region beyond the aforementioned range. The remaining dose for the second half (28 GyRBE for a total dose of 64 GyRBE, or 21.6 GyRBE for a total dose of 57.6 GyRBE) is defined as CTV2 for all cases, regardless of PNTS status, by adding a 3 mm margin to the GTV. The planning target volume (PTV) is defined by adding a 2 mm margin to both CTV1 and CTV2.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with histologically confirmed adenoid cystic carcinoma of the head and neck region. 2) Patients with measurable lesions. 3) Patients scheduled to undergo Carbon-ion Radiotherapy. 4) Patients aged 18 years or older. 5) Patients with a Performance Status (PS) of 0-2. 6) Patients who have been informed of their diagnosis and condition and possess the capacity to consent. Key exclusion criteria - 1) Patients with a history of radiation therapy to the target treatment area. 2) Patients with active, refractory infection at the irradiation site. 3) Patients with severe complications (e.g., poorly controlled diabetes, myocardial infarction requiring urgent intervention, unstable angina, poorly controlled arrhythmia, bleeding tendency due to untreated hemorrhagic disease, collagen disease requiring steroid administration). 4) Patients with active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to carcinoma in situ or mucosal carcinoma, deemed curable by local therapy, are not included in active multiple cancers. 5) Other individuals deemed unsuitable by the attending physician due to medical, psychological, or other factors. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 26 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2036 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067715

Disclaimer: Curated by HT Syndication.