International Collaborative Clinical Studies for Germ Cell Tumors (AGCT1531)

Abstract

Germ cell tumors are diverse, ranging from benign tumors such as mature teratomas to extremely aggressive tumors, with the developmental origins thereof also divided into the gonadal and extragonadal areas. Therefore, histopathological classification is complicated and the grades of malignancy vary. Furthermore, there are biological differences depending on age, with differences in prognosis depending on the primary site. In addition, there are differences in approaches and treatment strategies, particularly for gonad germ cell tumors in children and adults. Therefore, it was considered necessary to establish a unified staging system and a new risk classification, which lead to the establishment of an international consortium for malignant germ cell tumors (MaGIC) centered around the Children’s Oncology Group (COG). Challenges such as over-treatment for low-risk cases, reduction of treatment complications, and the establishment of standard treatment for high-risk cases were pointed out as issues to be reviewed by an international collaborative clinical study. Currently, an international collaborative clinical study (AGCT1531) is underway, under the leadership of COG, wherein the following two tests are being conducted: (1) for the standard-risk group, a randomized study with BEP therapy is being conducted on a protocol change to carboplatin for the purpose of avoiding late toxicity of cisplatin in conventional BEP therapy; (2) for the low-risk group, not only for the testes, which had a good prognosis in the past, but also for stage 1 cases of all primary lesions, surgical monotherapy is being conducted and monitored in order to verify the non-inferiority thereof to conventional chemotherapeutic combination therapy. The JCCG Germ Cell Tumor Committee in Japan is also playing a central role in this international collaborative clinical study, which is limited to 16 major domestic facilities, with case registrations currently initiated.