The National Cancer Center Japan has entered into an agreement with Sumitomo Heavy Industries, STELLA PHARMA CORPORATION, and Cancer Intelligence Care Systems, Inc. to conduct a Phase I/II basket trial of Boron Neutron Capture Therapy (BNCT) for patients with unresectable and recurrent thoracic malignant solid tumors who are not candidates for standard therapies. This marks the world's first clinical trial of BNCT encompassing several types of thoracic cancer.
The trial aims to evaluate the safety and efficacy of BNCT, as well as the utility of [18F]F-BPA PET imaging in assessing the applicability of BNCT for individual patients. By grouping several cancer types, the researchers hope to shorten the development period compared to conducting individual clinical trials for each cancer type. The study will include patients with esophageal cancer, non-small-cell lung cancer, breast cancer, malignant soft tissue sarcoma in the thorax, and malignant pleural mesothelioma, among others.
Trial Design and Objectives
The basket trial will enroll patients who are not eligible for standard radiation therapy and/or drug therapy and who have the same organs at risk as BNCT based on X-CT with treatment posture. The organs at risk include the lungs, heart, liver, spinal cord, and esophagus. The primary objectives are to evaluate the safety and efficacy of BNCT and to assess the safety of [18F]F-BPA PET imaging before BNCT. An exploratory objective is to evaluate the usefulness of [18F]F-BPA PET imaging in determining patient suitability for BNCT.
BNCT and FBPA-PET
BNCT is a targeted radiation therapy that utilizes a boron compound, L-4-boronophenylalanine (BPA), to selectively accumulate boron in tumor cells. The tumor is then irradiated with neutrons, leading to the selective destruction of cancer cells while sparing surrounding healthy tissue. FBPA (2-fluor-4-boronophenylalanine) is used in positron emission tomography (PET) imaging to measure the amount of boron accumulated in the target tumor.
Unmet Medical Needs
Currently, patients with recurrent thoracic malignancies who have already undergone standard initial treatments often have limited local therapy options beyond drug therapy. This clinical trial seeks to address this unmet need by exploring the potential of BNCT as a viable treatment option. The trial is scheduled to continue until October 31, 2028.
