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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036809
Receipt No. R000041765
Scientific Title Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for refractory head & neck and breast cancer
Date of disclosure of the study information 2019/05/25
Last modified on 2019/06/21

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Basic information
Public title Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for malignant solid tumors
Acronym Clinical Study of HB-001 brachytherapy in Japan
Scientific Title Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for refractory head & neck and breast cancer
Scientific Title:Acronym Clinical Study of HB-001 brachytherapy in Japan
Region
Japan

Condition
Condition Head and neck cancer or breast cancer
Classification by specialty
Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the HB-001 brachytherapy in patient with recurrent solid malignant cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction in tumor size 10weeks after the HB-001 brachytherapy operation(RECIST1.1)
Key secondary outcomes Incidence, severity, and frequency of adverse events (AE) related to the device
ECOG performance status

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The HB-001 seeds are inserted into the tumor at an interval of up to 5 mm. The seeds are removed 14-22 days after the implantation
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 >Head and neck cancer or breast cancer patients with histopathologically proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
>Tumor size is 5 cm or less in the longest diameter
>Age 18 years or older
>ECOG performance status is 2 or less
0: Fully active, able to carry on all pre-disease performance without restriction
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. E.g., light house work, office work
2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
>Life expectancy: 6 months or longer
>Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
>Platelet count >= 100,000/mm3 and prothrombin time PT-INR <= 1.8
>WOCBP have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.
>Having received explanation about the study, consented to participate in the study and signed the informed consent form.
>Measurable disease according to RECIST v1.1
Key exclusion criteria >The size of the tumor more than 5 cm in the maximum diameter.
>ECOG performance status is 3 or higher
3: Capable of only limited selfcare. Confined to bed or chair more than 50% of waking hours.
4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
>Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
>History of serious allergy to the medicine for the treatments like anesthesia.
>There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
>Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
>Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
>Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy
>Pregnant women or breast-feeding mothers
>Those who do not wish to sign the informed consent form
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Shomoto
Organization Hekabio K.K.
Division name R&D, Medical dev.&PV
Zip code 103-0027
Address 1-12-8 Nihonbashi, Chuo-ku Tokyo
TEL 03-6205-7585
Email koji.shomoto@hekabio.com

Public contact
Name of contact person
1st name Koji
Middle name
Last name Shomoto
Organization Hekabio K.K.
Division name R&D, Medical dev.&PV
Zip code 103-0027
Address 1-12-8 Nihonbashi, Chuo-ku Tokyo
TEL 03-6205-7585
Homepage URL
Email HB-AT-001@hekabio.com

Sponsor
Institute Hekabio K.K.
Institute
Department

Funding Source
Organization Hekabaio K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hekabio K.K.
Address 1-12-8 Nihonbashi, Chuo-ku Tokyo
Tel 03-6205-7585
Email koji.shomoto@hekabio.com

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 国立がん研究センター中央病院(東京都)、東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 25 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
2019 Year 02 Month 25 Day
Date of IRB
2018 Year 11 Month 05 Day
Anticipated trial start date
2019 Year 05 Month 25 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 21 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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