A phase III trial comparing irinotecan and cisplatin with etoposide and cisplatin in adjuvant chemotherapy for completely resected pulmonary high-grade neuroendocrine carcinoma (JCOG1205/1206)

Junko Eba, Hirotsugu Kenmotsu, Masahiro Tsuboi, Seiji Niho, Hiroshi Katayama, Taro Shibata, Shun ichi Watanabe, Noboru Yamamoto, Tomohide Tamura, Hisao Asamura

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19 Citations (Scopus)

Abstract

A randomized Phase III trial commenced in Japan in March 2013. Post-operative adjuvant chemotherapy with etoposide plus cisplatin is the current standard treatment for resected pulmonary high-grade neuroendocrine carcinoma including small cell lung cancer and large cell neuroendocrine carcinoma. The purpose of this study is to confirm the superiority of irinotecan plus cisplatin in terms of overall survival over etoposide plus cisplatin as post-operative adjuvant chemotherapy for pathological Stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma patients. A total of 220 patients will be accrued from 54 Japanese institutions within 6 years. The primary endpoint is overall survival and the secondary endpoints are relapse-free survival, proportion of treatment completion, adverse events, serious adverse events and second malignancy.

Original languageEnglish
Article numberhyt233
Pages (from-to)379-382
Number of pages4
JournalJapanese journal of clinical oncology
Volume44
Issue number4
DOIs
Publication statusPublished - 2014 Apr
Externally publishedYes

Keywords

  • Adjuvant chemotherapy
  • High-grade neuroendocrine carcinoma
  • Lung neoplasms
  • Phase III

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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