Investigator-Initiated Registration Directed Trials, or Advanced Medical Care conducted by GOTIC and NRG-Oncology Japan

Abstract

Abstract NRG Oncology-Japan is a group of Japanese institutions participating in NCI-sponsored academic studies as an international member of NRG Oncology (NRG), which is one of the cancer clinical research groups under NCI. At the same time as conducting investigator-initiated clinical trials for gynecologic cancer, breast cancer and brain tumors, we are developing new drugs for approval application in Japan as investigator-initiated trials. Especially in the gynecologic cancer area, from the GOG era, one of NRG s predecessor groups, we conducted investigator-initiated clinical trials (GOG 218 trial) aiming for approval for ovarian cancer of bevacizumab and work on advanced medicine (GOG 213 trial), and then, chieved approval. Currently, we are conducting both GY004 and GY005 trials as investigator-initiated trials with the aim of approving recurrent ovarian cancer from olaparib and cediranib. GOTIC (North Kanto Gynecologic Cancer Clinical Trials Consortium) is a gynecological cancer clinical trials group (general incorporated corporation) established in 2009. So far, a phase 3 comparative study (iPocc study) to verify the usefulness of intraperitoneal administration of carboplatin has been carried out as an international collaboration study (advanced medical care in Japan) based on AMED funds. In addition, the PAOLA-1 trial aimed at the combined approval of olaparib and bevacizumab for ovarian cancer is being conducted as a doctor-led clinical trial led by GINECO, a gynecological cancer clinical trial group in France. The role of the Study Coordination Center is extremely important for the smooth execution of these physician-led clinical trials and physician-led clinical trials. I would like to introduce the efforts and problems at NRG Japan, GOTIC, focusing on the relationship with the coordinating center.