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)
- Conditions
- advanced neuroendocrine carcinoma of the digestive system
- Registration Number
- JPRN-UMIN000014795
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 170
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method