AI Article Synopsis
- A Phase III trial, launched in Japan in March 2013, aims to compare the efficacy of irinotecan plus cisplatin against the standard treatment of etoposide plus cisplatin for patients with resected pulmonary high-grade neuroendocrine carcinoma.
- The study involves 220 patients and focuses on overall survival as the primary endpoint, alongside secondary endpoints like relapse-free survival and treatment-related adverse events.
- It is registered under UMIN000010298 in the UMIN Clinical Trials Registry, reflecting its commitment to rigorous clinical research standards.
Article 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. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000010298 [http://www.umin.ac.jp/ctr/index.htm].
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| http://dx.doi.org/10.1093/jjco/hyt233 | DOI Listing |
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