UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060367 |
|---|---|
| Receipt number | R000068865 |
| Scientific Title | An Observational Study on Effectiveness and Safety of Alluminox therapy for recurrent Nasopharyngeal carcinoma |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/15 16:32:40 |
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Basic information
Public title
An Observational Study on Effectiveness and Safety of Alluminox therapy for recurrent Nasopharyngeal carcinoma
Acronym
NPC-PIT
Scientific Title
An Observational Study on Effectiveness and Safety of Alluminox therapy for recurrent Nasopharyngeal carcinoma
Scientific Title:Acronym
NPC-PIT
Region
| Japan |
Condition
Condition
Nasopharyngeal carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
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
Basic objectives -Others
This study aims to evaluate the efficacy and safety of head and neck Aluminox therapy in patients who have received or are scheduled to receive this treatment. Clinicopathological factors (patient background, lesion site, local findings, and histological diagnosis), clinical course (intraoperative findings, treatment efficacy, adverse events, and outcomes), and image profiles obtained from routine pathological and imaging examinations will be collected. Residual tumor tissue obtained during routine clinical care will be analyzed to assess tumor molecular profiles using immunohistochemistry (IHC). In patients who provide written informed consent prior to treatment initiation, blood samples will be collected for circulating tumor DNA (ctDNA) analysis. The associations between these factors and the efficacy and safety of head and neck Aluminox therapy will be examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Shinozaki |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa City, Chiba, Japan
TEL
04-7133-1111
npc-pit-office@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shinozaki |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa City, Chiba, Japan
TEL
04-7133-1111
Homepage URL
npc-pit-office@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Rakuten Medical Inc.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1,tsukiji,chuo-ku,Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068865
