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

Not Applicable

• Conditions: nresectable locally recurrent head and neck squamous cell carcinoma Unresectable head and neck non-squamous cell carcinoma

• Registration Number: JPRN-UMIN000040501
• Lead Sponsor: Southern Tohoku BNCT Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-23
• Study Completion: 2023-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
-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