UMIN-CTR Clinical Trial

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
Institute	Southern Tohoku BNCT Research Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046228