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

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 - JHN002 Look Up Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040501

Enrollment

Registered

2020-05-23

Start date

2016-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Japan

Contacts

Public ContactKatsumi Hirose

Southern Tohoku BNCT Research Center Department of Radiation Oncology

khirose@hirosaki-u.ac.jp+81-24-934-5330

Outcome results