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).

Abstract:

: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).

journal_name

Jpn J Clin Oncol

authors

Eba J,Shimokawa T,Nakamura K,Shibata T,Misumi Y,Okamoto H,Yamamoto N,Ohe Y,Lung Cancer Study Group of the Japan Clinical Oncology Group.

doi

10.1093/jjco/hyu166

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

115-8

issue

1

eissn

0368-2811

issn

1465-3621

pii

hyu166

journal_volume

45

pub_type

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