Clinical Trial: An Observational Study on Effectiveness and Safety of Alluminox therapy for recurrent Nasopharyngeal carcinoma (Japan)

Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060367) titled 'An Observational Study on Effectiveness and Safety of Alluminox therapy for recurrent Nasopharyngeal carcinoma' on Jan. 15.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center Hospital East

Condition: Condition - Nasopharyngeal carcinoma Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - This study aims to evaluate the efficacy and safety of head and neck Aluminox therapy in patients with locally recurrent nasopharyngeal carcinoma after radiotherapy conducted as part of standard insurance-covered medical care. In addition, exploratory analyses will be performed to identify biomarkers associated with treatment efficacy and resistance, and to investigate the underlying mechanisms of the antitumor effects of head and neck Aluminox therapy. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients who have provided written informed consent to participate in this study, or patients for whom no refusal has been expressed through an opt-out process. 1.1 If the patient has difficulty providing written consent, written informed consent may be obtained through a proxy signer under the patient's oral consent. 1.2 If the patient is objectively judged to lack the capacity to provide informed consent, written informed consent may be obtained from a legally acceptable representative in accordance with ethical guidelines. 1.3 If it is difficult toDS to obtain written informed consent from the patient or a legally acceptable representative, the patient may be enrolled provided that no refusal has been expressed through the opt-out process. 2. Patients aged 18 years or older at the time of consent acquisition, or at the time of the first administration of Akalux if head and neck Aluminox therapy has already been initiated. 3. Patients diagnosed with unresectable locally advanced or locally recurrent nasopharyngeal carcinoma. 4. Patients with a history of radiotherapy to the head and neck region. 5. Patients who have received or will receive head and neck Aluminox therapy at least once between January 2021 and March 2026 under health insurance coverage, using Akalux and the BioBlade laser system in accordance with the approved indications, dosage, and administration. 6. Patients for whom imaging data such as MRI or CT used for lesion evaluation are available. 7. Patients for whom procedural information related to head and neck Aluminox therapy is available. Key exclusion criteria - Patients who meet any of the following exclusion criteria will be excluded from this study. 1. Patients who meet the contraindications for Akalux as described in the latest package insert. If the patient has already received head and neck Aluminox therapy, this applies to those who met the contraindications at the time of Akalux administration. 2. Patients who were participating in another interventional study at the time of Akalux administration if head and neck Aluminox therapy has already been initiated, or patients who are scheduled to participate in another interventional study during head and neck Aluminox therapy. 3. Patients who are judged to be inappropriate for inclusion in this study by the principal investigator or sub-investigators. Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2023 Year 09 Month 11 Day Date of IRB - 2023 Year 10 Month 10 Day Anticipated trial start date - 2023 Year 10 Month 26 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068865

Disclaimer: Curated by HT Syndication.