NCT05883007

Dose Optimized BNCT for Head and Neck Cancer

Safety Cohort Study for Dose Optimization of Accelerator-based BPA-BNCT in Patients With Unresectable Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (ST-BNCT2001)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Southern Tohoku BNCT Research Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are: \- Dose optimized BNCT are conducted safety in these patients. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Accelerator-based BNCT with borofalan(10B)	Patients will be treated with BNCT regulated as 12, 15, or 18 Gy-Eq of the mucosal maximum dose.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-05-31
• Completion: 2024-05-31
• First posted: 2023-05-31
• Last updated: 2023-06-05

Locations

1 site across 1 country: Japan