jRCTs051180160CompletedNot Applicable
Establishment of protocol for neutron capture therapy for head and neck cancer (BNCT for HNC)
Not provided0 sites10 target enrollmentStarted: January 31, 2013Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 80age old under (—)
- Sex
- All
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
- •(9)Written informed consent with one own will .
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.
Outcomes
Primary Outcomes
-
Overall response rate
Secondary Outcomes
No secondary outcomes reported
Investigators
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