Neutron capture therapy for head and neck cancer

Establishment of protocol for neutron capture therapy for head and neck cancer - BNCT for HNC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051180160

Enrollment

Registered

2019-03-25

Start date

2013-01-31

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

0-1 Head and Neck Cancer, BNCT

Interventions

cancer treatment protocol

D024221

Head and Neck Cancer, BNCT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)The patient with local recurrence of head and neck cancer who can not perform the standard therapy any more after radiotherapy. (2)The patient with local recurrence of head and neck cancer by the imaging diagnosis, such as CT, MRI and PET. (3)The patient with previous radiotherapy (total 40-75 Gy, 2Gy/fq) for the recurrent region. (4)The patient with the period of more than one month since the previous treatment. (5)The patient with recurrence lesion in the less than 6cm of depth from skin as GTV for BNCT. (6)The Patients who have PS less than 2 and are expected to survive more than 6 months after BNCT. (7)The patient with good condition of renal function: creatinine <1.2 mg/dl for male and <1.0 mg/dl for female. (8)The patient with the age between 20 and 80. (9)Written informed consent with one own will .

Exclusion criteria

Exclusion criteria: (1)The patient with active multiple primary cancers; synchronous or metachronous (within 5 years) double cancers . (2)The patient with metastatic lesion. (3)The patients with severe complications. (4)The patients with infection requiring systemic treatment. (5)The patient with severe adverse event (>Grade3, CTCAE v4.0) in the BNCT region. (6)The patient with cardiac pacemaker. (7)The patient judged to have difficulty in maintain posture during the protocol treatment. (8)The patient with WBC; < 3000/mm3, PLT; < 100000/mm3 (9)The patient with recurrence lesion invasive to carotid artery and toskin. (10)Patients with phenylketonuria. (11)Patients considered medically or socially inappropriate.

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Adverse event rate Progression free survival Overall survival	—

Contacts

Public ContactIchiro Ota

Nara Medical University Hospital

iota@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026