Patients
HER2-negative cancer, cancer, gastric adenocarcinoma
ONCOLOGY, CANCER, RECURRENT DISEASE, GASTRIC ADENOCARCINOMA
The Tokyo Cooperative Oncology Group (TCOG) GI-1601 study is a multicenter, prospective, phase II trial to examine the efficacy and safety of CapeOX in Japanese older patients with AGC. The inclusion criteria comprised: histologically diagnosed gastric adenocarcinoma and HER2-negative cancer or cancer of unknown cause; unresectable, metastatic, or recurrent disease; adequate self-supported nutritional intake; age ≥ 70 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; no history of chemo- or radiotherapy; adequate organ function as defined by a hemoglobin level ≥ 8 g/dL, white blood cell count ≤ 12,000/mmAll patients provided written informed consent before enrollment. The study was performed in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Studies in Japan and was approved by the ethics committees of TCOG and each participating center before initiating enrollment. An Independent Data Monitoring Committee (IDMC) reviewed all efficacy and safety protocols. This study was registered in UMIN-CTR under code UMIN000022450 and in the Japan Registry of Clinical Trials under code jRCTs051180126.