A Phase II/III study comparing carboplatin and irinotecan with carboplatin and etoposide for the treatment of elderly patients with extensive-disease small-cell lung cancer (JCOG1201)

作者：Eba Junko; Shimokawa Tsuneo^*; Nakamura Kenichi; Shibata Taro; Misumi Yuki; Okamoto Hiroaki; Yamamoto Noboru; Ohe Yuichiro

来源：Japanese Journal of Clinical Oncology, 2015, 45(1): 115-118.

DOI：10.1093/jjco/hyu166

• small-cell lung carcinoma
• extensive-disease
• elderly
• chemotherapy
• Phase II/III

A randomized Phase II/III trial commenced in Japan in December 2013. Carboplatin plus etoposide is the current standard treatment for elderly extensive-disease small-cell lung cancer. The purpose of this study is to confirm the superiority of carboplatin plus irinotecan in terms of overall survival over carboplatin plus etoposide for elderly extensive-disease small-cell lung cancer patients in a Phase II/III design. A total of 370 patients will be accrued from 38 Japanese institutions within 5 years. In the Phase II part, the primary endpoint is the response rate of the carboplatin plus irinotecan arm and the secondary endpoint is adverse events. In the Phase III part, the primary endpoint is overall survival and the secondary endpoints are progression-free survival, response rate, adverse events, serious adverse events and symptom score. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012605 (http://www.umin.ac.jp/ctr/index.htm).

• 出版日期2015-1