Randomized phase III study of etoposide plus cisplatin combination therapy versus irinotecan plus cisplatin combination therapy in advanced neuroendocrine carcinoma of the digestive system. (JCOG1213,TOPIC-NEC)

UMIN ID: UMIN000014795

Registered date:08/08/2014

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: advanced neuroendocrine carcinoma of the digestive system
• Date of first enrollment: 2014/08/08
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Chemotherapy with etoposide (100 mg/m2/day, day 1,2,3) and cisplatin (80 mg/m2/day, day 1) repeated every 3 weeks
B: Chemotherapy with irinotecan (60 mg/m2/day, day 1,8,15) and cisplatin (60 mg/m2/day, day 1) repeated every 4 weeks

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Response rate, Progression free survival, Adverse events, Dose intensity of cisplatin, Serious adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Fever of 38 degrees Celsius or higher 4) Pregnant or lactating women, women of childbearing potential, or women within 28 days after delivery 5) Psychiatric disease 6) Patients requiring systemic steroids medication 7) Interstitial pneumonia, pulmonary fibrosis 8) Serious co-existing illness 9) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 10) Impossible to use both iodine and gadolinium due to being allergic to contrast agent 11) Uncontrolled diabetes mellitus or routine administration of insulin

Related Information

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development