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Table 1 Inclusion and exclusion criteria for the fractionated BNCT clinical trial

From: Clinical trials for treating recurrent head and neck cancer with boron neutron capture therapy using the Tsing-Hua Open Pool Reactor

Inclusion criteria Exclusion criteria
1. Patients with locoregionally recurrent and histologically proved malignancy of the head and neck
2. Prior conventional radiotherapy administered has been given for the disease (except melanoma)
3. Bi-dimensionally measurable disease by MRI and/or CT scan and  12 cm in the largest dimension
4. Age > 18 and < 80 years, ECOG performance status  2
5. WBC > 2.5 × 109/L, neutrophil count > 1.0 × 109/L, platelet count > 7.5 × 109/L, serum creatinine < 1.25 × ULN
6. Tumor to normal tissue (T/N) ratio for BPA > 2.5 by 18F-BPA PET scan
1. Lymphoma or other tumor type that is expected to respond to chemotherapy or conventional radiation therapy that can be safely given
2. Patients who had an effective standard treatment option like surgery or radiotherapy available
3. Distant metastasis outside the head and neck regions
4. Expected life less than 3 months
5. A time interval less than 3 months from previous radiation therapy
6. Concurrent systemic cancer treatment including chemotherapy or target therapy
7. Pregnancy
8. Restless patients who were unable to lie or sit in a cast for 30–60 min
  1. BNCT boron neutron capture therapy, MRI magnetic resonance imaging, CT computed tomography, ECOG eastern cooperative oncology group, WBC white blood cell, ULN upper limit of normal, BPA boronophenylalanine, 18F-BPA PET 18-Fluoro-labeled BPA positron emission tomography