UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Southern Tohoku BNCT Research Center

Institute

Department

Personal name

Organization

Southern Tohoku BNCT Research Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

05

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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