Nasopharyngeal carcinoma
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the antitumor response (objective response rate) of each irradiated lesion evaluated according to the RECIST criteria. For lesions that can be visualized on imaging studies (CT, MRI, PET/CT), response will be assessed based on imaging findings. For lesions that are difficult to evaluate by imaging, response will be assessed based on endoscopic findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the complete response (CR) rate of each irradiated lesion evaluated according to the RECIST criteria; overall tumor response per patient (objective response rate and CR rate) assessed by RECIST; treatment-related adverse events; the emergence of lesions outside the irradiated fields; and associations between the efficacy and safety of head and neck Aluminox therapy and clinicopathological factors, treatment course, imaging profiles, tumor tissue molecular profiles, and circulating tumor DNA (ctDNA) profiles. | — |
Countries
Japan
Contacts
Public ContactTakeshi Shinozaki
National Cancer Center Hospital East Head and Neck Surgery
Outcome results
None listed