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.

JRCT ID: jRCTs031180005

Registered date:23/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: advanced neuroendocrine carcinoma of the digestive system
• Date of first enrollment: 14/08/2014
• Target sample size: 170
• 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: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

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: OKUSAKA Takuji
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000014795