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

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