advanced neuroendocrine carcinoma of the digestive system
Conditions
Interventions
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/
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven neuroendocrine carcinoma (NEC). 2) NEC arise in esophagus, stomach, duodenum, intestine, appendix, colon, rectum, gallbladder, intrahepatic bile duct, extrahepatic bile duct, ampulla of Vater, pancreas, and liver. 3) Unresectable or recurrent cancer; Patients with the following are not eligible: cT4, no distant metastasis rather than supraclavicular lymph node, or stenosis indicated for palliative radiotherapy for esophageal NEC. 4) No previous chemotherapy or radiotherapy for NEC. Pre- or post-operative chemotherapy except irinotecan or etoposide for NEC is allowed as long as it was completed at least 8 weeks prior to registration. 5) No previous chemotherapy using platinum agents for any malignancies 6) Aged 20 to 75 years old 7) ECOG performance status of 0 or 1 8) Measurable region is not required 9) Adequate organ functions 10) Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Progression free survival, Adverse events, Dose intensity of cisplatin, Serious adverse events | — |
Countries
Japan
Contacts
Public ContactChigusa Morizane
JCOG1213 Coordinating Office National Cancer Center, Tokyo Hepatobiliary and Pancreatic Medical Oncology
Outcome results
None listed