NIPH Clinical Trials Search

UMIN ID: UMIN000001246

Registered date:15/07/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedextensive-disease small-cell lung cancer
Date of first enrollment2008/07/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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.


Primary Outcomeoverall survival (1-year survival rate)
Secondary Outcomeprogression free survival response rate safety (incidence of an adverse event)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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


public contact
Name Saori Kato
Address 460-0002 P-A Bldg. 3F,2-14-10 Marunouchi,Naka-ku, Nagoya,Aichi, Japan Japan
Telephone 052-218-3301
Affiliation The Japan-multinational Trial Organization The Japan-multinational Trial Organization datacenter
scientific contact
Name Hiroshige Yoshioka
Address 1-1-1, Miwa, Kurashiki, Okayama 710-8602, Japan Japan
Telephone 086-422-0210
Affiliation Kurashiki Central Hospital Department of Respiratory Medicine