Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and
      locally recurrent head and neck cancer. The primary end points are treatment toxicities and
      response rate. The secondary endpoints are time to tumor progression, progression-free
      survival, overall survival and change quality of life.

      Head and neck carcinomas that recur locally after conventional irradiation pose a therapeutic
      challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture reaction that
      occurs when non-radioactive boron is irradiated with neutrons of thermal energy to yield high
      energy alpha particles and recoiling lithium nuclei. The effect of alpha and 7Li is primarily
      limited to boron- containing cells. Preferential uptake of boron into cancerous tissue is
      achieved using boron carriers such as a derivative of phenylalanine, boronophenylalanine
      (BPA). After administration of BPA by an intra-arterial or intravenous infusion, the tumor
      site is irradiated with neutrons, the source of which is currently a nuclear reactor. A few
      uncontrolled clinical trials have evaluated BNCT in the treatment of glioblastoma after brain
      surgery. In these studies, the median survival times have been 13-15 months after BNCT.
      However, efficacy and tolerability of BNCT in the treatment of limited number of head and
      neck cancer patients showed promising results. Though many basic researches about BNCT has
      been done using Tsing Hua Open-pool Reactor (THOR) at National Tsing Hua University, no
      clinical trial utilizing BNCT is performed in our country. This study will be the first BNCT
      trial to treat head and neck cancer in Taiwan.
    

Detailed description: 
      This is a prospective, single arm, open label phase I/II trial with boron neutron capture
      (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck
      cancer.

      The eligibility criteria are patients with locoregionally recurrent head and neck cancer;
      good performance status; inoperable, clinical measurable tumor size; good organ function and
      good compliance. No systemic treatment is in use. Once entering this study, patients will
      receive angiographies to evaluate bloody supply of the tumor and PET scan with
      18F-fluoro-L-BPA as the tracer. Tumor-to- normal tissue ratios were evaluated from static
      emission scans. Boron concentration of normal tissues is derived from measurement of BPA
      concentration in the blood. Treatment planning with THORplan will be done after Computerized
      Tomography (CT) simulation. After treatment plan approved and on the day of treatment,
      intravenous or intra-arterial L-BPA- Fructose complex 500 mg/kg was administered at a
      constant rate over about 3 hours before and during neutron irradiation. Neutron beam
      irradiations were given at the THOR with prescription dose of 20 to 25 Gy (Eq) for the tumor
      in one fraction on day 1 and repeated on day 30. Patients will be regularly followed up at
      OPD for toxicities (NCI Common Terminology Criteria) and response evaluation (RECIST
      criteria)by MRI and PET, time to progression measurement, survival status and change of
      quality of life. Maximally 27 patients will be enrolled. After first 10 patients, the
      preliminary results will be reviewed before further patients' enrollment.
    

Intervention name(s): Boron Neutron Capture Therapy
Intervention type(s): Radiation
Intervention description(s): Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)
Intervention MeSH terms: Boron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Boron neutron capture therapy (BNCT); Head and neck cancer; toxicities; response rate