Neutron capture therapy for head and neck cancer

JRCT ID: jRCTs051180160

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: 0-1
• Date of first enrollment: 31/01/2013
• Target sample size: 10
• Study type: Interventional
• Intervention(s): cancer treatment protocol

Outcome(s)

• Primary Outcome: Overall response rate

Secondary Outcome

Adverse event rate
Progression free survival
Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 .

Exclude 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.

Related Information

• Primary Sponsor: Ota Ichiro
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research