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

Neutron capture therapy for head and neck cancer (BNCT for HNC)

7

The patient with local recurrence of head and neck squamous cell carcinoma who can not perform the standard therapy anymore after radiotherapy.

We were almost able to register the patients as scheduled.

Alopecia: Grade 2, 5 cases. Dermatitis: Grade 3, 2 cases; Grade 2, 3 cases. Pharyngeal mucositis: Grade 2, 3 cases. Dysphagia: Grade 3, 1 case; Grade 2, 1 case. Headache: Grade 2, 1 case; Grade 1, 1 case. Depressed level of consciousness: Grade 4, 1 case.

Treatment effect: (n=7) CR: 2 cases (28.6 %) PR: 4 cases (57.1 %) SD: 1 case (14.3 %) The overall response rate was 85.7%.

The overall response rate to BNCT for recurrent advanced head and neck cancer was 85.7 %, suggesting a good therapeutic effect. In refractory temporal cases, dysphagia as an adverse event was somewhat prolonged, but there were no serious adverse events such as hematologic toxicity. If the local infection could be controlled, long-term quality of survival (QoS) could be maintained.

Jan. 11, 2022

No

Not applicable

https://jrct.niph.go.jp/latest-detail/jRCTs051180160

Ota Ichiro

Nara Medical University Hospital

840 Shijo-cho Kashihara, Nara

iota@naramed-u.ac.jp

Ota Ichiro

Nara Medical University Hospital

840 Shijo-cho Kashihara, Nara

+81-744-22-3051

iota@naramed-u.ac.jp

Complete

Jan. 31, 2013

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

(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 .

(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.

Both

0-1

cancer treatment protocol

Head and Neck Cancer, BNCT

Head and Neck Cancer, BNCT

D006258

D024221

Overall response rate

Adverse event rate
Progression free survival
Overall survival

+81-744-29-8835

Mar. 08, 2019

none