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).
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].
*Division of Thoracic Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. h.kenmotsu@scchr.jp.
Junko
J
Eba
Hirotsugu
H
Kenmotsu
Masahiro
M
Tsuboi
Seiji
S
Niho
Hiroshi
H
Katayama
Taro
T
Shibata
Shun-ichi
S
Watanabe
Noboru
N
Yamamoto
Tomohide
T
Tamura
Hisao
H
Asamura
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018278:Carcinoma, Neuroendocrine / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D002985:Clinical Protocols; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015994:Incidence; D000077146:Irinotecan; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009367:Neoplasm Staging; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D018579:Patient Selection; D016019:Survival Analysis; D016896:Treatment Outcome
D005047:Etoposide; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin
Phase III; adjuvant chemotherapy; high-grade neuroendocrine carcinoma; lung neoplasms