Boron neutron capture therapy using cyclotron-based epithermal neutron source for squamous cell carcinoma of the head and neck refractory to standard treatments: An open-label phase II trial
- Conditions
- unresectable squamous cell carcinoma of the head and neck refractory to standard treatments
- Registration Number
- JPRN-UMIN000044118
- Lead Sponsor
- Department of Radiation Oncology, Southern Tohoku BNCT Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Not provided
1. Patients (Pts) with active multiple cancers, not including lesions equivalent to carcinoma in situ or skin cancer considered healed 2. Pts with distant metastasis 3. Pts with active infections requiring systemic treatment 4. Pts with significant complications - Poorly uncontrolled diabetes - Poorly uncontrolled hypertension - Chronic lung disease - Kidney disease - Heart disease - Serious complications 5. Pts with phenylketonuria 6. Pts with hereditary fructose intolerance 7. Pts who have complications and a medical history with severe hypersensitivity reactions in drugs and contrast agents 8. Pts with myocardial infarction, unstable angina, uncontrolled arrhythmia within 6 months 9. Pts with over Grade 3 (CTCAE v4.0) in the target lesion site 10. Pts with the tumors invade the carotid artery or adjacent to more than halfway through the carotid artery, and considered not to manage the normal tissue between the carotid artery and membrane mucosa or skin by the treatments 11. Pts with decayed and untreated teeth 12. Pts with the administration of antineoplastic drug within 3weeks prior to the scheduled date of BNCT 13. Pts who were enrolled in unapproved drugs clinical study except for 18F-FBPA-PET/CT or who are participating in this clinical study within 4 weeks prior to the scheduled date of BNCT. Or patients will participate in unapproved drugs clinical study except for 18F-FBPA-PET/CT other clinical study during this study 14. Pts who have a cardiac pacemaker and auxiliary artificial heart 15. Pts who are considered unable to be fixed position during irradiation 16. Pts who complicated with psychiatric disorder or mental manifestation 17. Pts with poorly uncontrolled epilepsy 18. Pts who unable to comply with this clinical protocol and receive follow-up care 19. Other conditions that in the opinion of the investigator would preclude the subject's participation in a clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method