An Observational Study on Effectiveness and Safety of Akalux and BioBlade Laser System Based Illuminox Treatment in Patients with Locally Advanced or Recurrent Head and Neck Cancer

JRCT ID: jRCT1041210120

Registered date:26/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable locally advanced or locally recurrent head and neck cancer
• Date of first enrollment: 27/12/2021
• Target sample size: 75
• Study type: Observational

Outcome(s)

• Primary Outcome: Tumor response per illuminated lesion by tumor volume reduction rate

Secondary Outcome

1)Tumor response per patient according to RECIST version1.1
2)Tumor response per illuminated lesion according to RECIST version1.1
3)Frequency of treatment-related adverse events
4)Frequency of Identified and potential risks as described in the Japan RMP

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients who have given written informed consent to participate in this study.
2)Patients aged 20 years or older at the time of the first dose of Akalux if they had already received head and neck Illuminox treatment, or at the time of obtaining consent if they received head and neck Illuminox treatment after obtaining consent.
3)Patients with a diagnosis of unresectable locally advanced or locally recurrent head and neck cancer.
4)Patients who will receive or have already received at least one head and neck Illuminox treatment after obtaining consent under the indications, dosage, and administration described in the package inserts of Akalux and BioBlade Laser System in clinical practice.
5)Patients who can provide images (MRI, CT) used for lesion evaluation for head and neck Illuminox treatment.
6)Patients who can provide information regarding Illuminox therapeutic procedures for head and neck cancer

Exclude criteria

1)Patients with contraindications to Akalux are listed in the latest package insert. However, with patients who have already received head and neck Iluminox treatment, patients with contraindications at the time of Akalux administration will be excluded.
2)Patients who were participating in another interventional study at the time of the administration of Akalux if they were already receiving head and neck Illuminox treatment, or those who plan to participate in another interventional study during head and neck Illuminox treatment.
3)Other patients were judged to be inappropriate for this study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Hanai Nobuhiro
• Secondary Sponsor: Yu Suzuki