Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)

UMIN ID: UMIN000001246

Registered date:15/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: extensive-disease small-cell lung cancer
• Date of first enrollment: 2008/07/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A:Patients receive amrubicine on day 1 and irinotecan on days 1 and 8. Courses repeat every 3 weeks.
B:Patients receive cisplatin on day 1 and irinotecan on days 1, 8, and 15. Courses repeat every 4 weeks.

Outcome(s)

• Primary Outcome: overall survival (1-year survival rate)
• Secondary Outcome: progression free survival response rate safety (incidence of an adverse event)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)uncontrollable pleural, pericardial effusion or ascites 2)uncontrolled heart disease 3)uncontrolled diabetes mellitus 4)active infection 5)radiotherapy including pulmonary field 6)interstitial pneumonia/active lung fibrosis on chest x-ray 7)patients who has been taking steroid or immunosuppressant for any other disease 8)watery diarrhea, intestinal paralysis or obstruction 9)history of severe drug allergy 10)active concomitant malignancy 11)pregnant or lactating woman 12)patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: The Japan-multinational Trial Organization
• Source(s) of Monetary Support: None