UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040501
Receipt number R000046228
Scientific Title Post-Trial Observational Study for JHN002 (A Phase II Clinical Trial of the Combination of SPM-011 and BNCT Treatment System (BNCT30) in Patients With Unresectable Locally Recurrent Head and Neck Squamous Cell Carcinoma or Unresectable Head and Neck Non-Squamous Cell Carcinoma): JHN002 Look Up Study
Date of disclosure of the study information 2020/05/23
Last modified on 2020/05/23 15:35:37

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Basic information

Public title

Post-trial observational study for a phase II study of accelerator-BNCT for head and neck cancer (JHN002): JHN002 Look Up Study

Acronym

JHN002 Look Up Study

Scientific Title

Post-Trial Observational Study for JHN002 (A Phase II Clinical Trial of the Combination of SPM-011 and BNCT Treatment System (BNCT30) in Patients With Unresectable Locally Recurrent Head and Neck Squamous Cell Carcinoma or Unresectable Head and Neck Non-Squamous Cell Carcinoma): JHN002 Look Up Study

Scientific Title:Acronym

JHN002 Look Up Study

Region

Japan


Condition

Condition

Unresectable locally recurrent head and neck squamous cell carcinoma
Unresectable head and neck non-squamous cell carcinoma

Classification by specialty

Hematology and clinical oncology Oto-rhino-laryngology Radiology
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this clinical study is to evaluate the efficacy and safety of boron neutron capture therapy (BNCT) using SPM-011 and BNCT30 in patients with unresectable locally recurrent head and neck squamous cell carcinoma or unresectable head and neck non-squamous cell carcinoma with long observation period.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

- Locoregional progression-free survival
Time from the date of BNCT to first documented disease progression in locoregional area.

Key secondary outcomes

- Efficacy
- Duration of response
The duration of the response is the time from the confirmed achievement of CR or PR (whichever is recorded first) to the date of initial objectively confirmed recurrence or exacerbation.
- Response
The objective tumor response within 2 years of BNCT is evaluated using RECIST guidelines (version 1.1). Change in tumor size is evaluated as the proportion of tumo size in target lesions compared to baseline before BNCT.
- Overall survival
Time from the date of BNCT todeath from any cause up to the completion of the survival survey period.
- Safety
- Adverse events
Incidence and grading in the observation period


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who have signed written informed consent to participate in the post-trial observational study on their own free will.
2. Patients who were registered in JHN002 trial and treated with BNCT, and meeting at least one of the following conditions:
1) Patients whose follow-up period in JHN002 trial was ended
2) Patients whose follow-up period in JHN002 trial was discontinued without assessment of PD for some reason, and who consented to continuous follow-up at a BNCT facility. The reasons for discontinuation of follow-up in JHN002 trial will be expected that:
- The investigators confirm the increase in tumor size by macroscopic findings, endoscopic findings, and ultrasonography, before PD assessment by diagnostic imaging.
- The investigators intend further antitumor treatment in the future.
- The investigators intend to conduct unapproved fluoride-18 fluoroborono- phenylalanine positron emission tomography (18F-FBPA-PET) study.

Key exclusion criteria

1. Patients unable to comply with the protocol and to attend follow-up visits (because of mental, family, social, geographical, or other reasons).

Target sample size

21


Research contact person

Name of lead principal investigator

1st name Katsumi
Middle name
Last name Hirose

Organization

Southern Tohoku BNCT Research Center

Division name

Department of Radiation Oncology

Zip code

963-8052

Address

7-10 Yatsuyamada, Koriyama, Fukushima 963-8052 JAPAN

TEL

+81-24-934-5330

Email

khirose@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Katsumi
Middle name
Last name Hirose

Organization

Southern Tohoku BNCT Research Center

Division name

Department of Radiation Oncology

Zip code

963-8052

Address

7-10 Yatsuyamada, Koriyama, Fukushima 963-8052 JAPAN

TEL

+81-24-934-5330

Homepage URL


Email

khirose@hirosaki-u.ac.jp


Sponsor or person

Institute

Southern Tohoku BNCT Research Center

Institute

Department

Personal name



Funding Source

Organization

Southern Tohoku BNCT Research Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Southern Tohoku General Hospital

Address

7-115 Yatsuyamada, Koriyama, Fukushima JAPAN

Tel

+81-24-934-5322

Email

bnct.irb@mt.strins.or.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

2020 Year 05 Month 23 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

21

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

No longer recruiting

Date of protocol fixation

2016 Year 05 Month 18 Day

Date of IRB

2016 Year 05 Month 30 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation and surveys
After obtaining the subject's consent, the investigator of the medical institution will perform observation, surveys at the timing specified in "Timing of observation and surveys."

Timing of observation and surveys
Medical examination by physician
At every 3 months until 2 years, the investigator will examine the subject for anomalies by visual examination, palpation, and with a stethoscope and tapping.

CT/MRI examination
At every 3 months until 2 years, CT or MRI of the head and neck region will be performed, as much as possible, with a contrast medium.
Throughout the trial period, the examination methods and procedures must not be changed.
The investigators will evaluate the data according to the RECIST guidelines (version 1.1).

Observation of the skin at the irradiation site
At every 3 months until 2 years, the skin condition at the irradiation site will be observed.
To evaluate safety for the skin tissue at the irradiation site following BNCT, the skin at the irradiation site will be evaluated according to the grading system for dermatitis radiation defined in CTCAE v4.0.

Observation of the mucosa at the irradiation site
At every 3 months until 2 years, the mucosal condition at the irradiation site will be observed.
The condition of mucosa at the irradiation site will be evaluated according to CTCAE v4.0.

Adverse events
All adverse events to the end of the post-trial follow-up period (at the time of discontinuation of the observational study) will be recorded in the medical record. Ongoing adverse events at the end of the post-observation period will be traced until the adverse event concerned remains to be unchanged or resolving, or the post-trial follow-up period for the subject concerned ends.

Confirmation of survival
Taking the day of BNCT as the beginning date of overall survival calculation for each subject, the survival of each subject will be surveyed until 5 years after BNCT.


Management information

Registered date

2020 Year 05 Month 23 Day

Last modified on

2020 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name