JCOG1213: Randomized phase III study of etoposide plus cisplatin combination therapy versus irinotecan plus cisplatin combination therapy in advanced neuroendocrine carcinoma of the digestive system.
- Conditions
- advanced neuroendocrine carcinoma of the digestive system
- Registration Number
- JPRN-jRCTs031180005
- Lead Sponsor
- OKUSAKA Takuji
- Brief Summary
A randomized phase III study was conducted in patients with unresectable or recurrent NEC of gastrointestinal or hepatobiliary origin, and the overall survival of EP and IP arms was tested in a two-sided manner. In the primary analysis for all enrolled patients, there was no significant difference in survival. There was also no significant difference in the sensitivity analyses for all eligible patients and those eligible for central pathological diagnosis. Please find the detailed summary in the CSR.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 170
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.
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 Overall survival
- Secondary Outcome Measures
Name Time Method Response rate, Progression free survival, Adverse events, Dose intensity of cisplatin, Serious adverse events